Suture passing systems and methods

ABSTRACT

An implant manipulator may have a distal end that retains an implant, a proximal end, and an intermediate portion between the ends. The implant manipulator may be a needle for a suture passer, with a suture capture feature at the distal end. The suture capture feature may have first and second members that flex apart to permit entry of the suture into a suture capture hole wherein the suture is retained until released. A suture passer may include one or more needles. The suture passer may also include a pusher; a distal end with a sharp, blade-like extension; or a side-loading distal end.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/166,012 filed on Oct. 19, 2018, entitled SUTURE PASSINGSYSTEMS AND METHODS, which is a continuation of U.S. patent applicationSer. No. 15/074,670, filed on Mar. 18, 2016, entitled SUTURE PASSINGSYSTEMS AND METHODS, which is a continuation of InternationalApplication No. PCT/US2014/056408, filed on Sep. 18, 2014, entitledSUTURE PASSING SYSTEMS AND METHODS, which claims the benefit of U.S.Provisional Application No. 61/879,388, filed on Sep. 18, 2013, entitledSUTURE PASSING SYSTEMS AND METHODS. U.S. patent application Ser. No.15/074,670 is also a continuation-in-part of U.S. patent applicationSer. No. 13/779,595 filed on Feb. 27, 2013, entitled SURGICAL APPARATUSAND METHOD, which issued on Feb. 21, 2017 as U.S. Pat. No. 9,572,566,and U.S. patent application Ser. No. 13/779,652 filed on Feb. 27, 2013,entitled SURGICAL APPARATUS AND METHOD. U.S. patent application Ser.Nos. 13/779,595 and 13/779,652 claim the benefit of U.S. ProvisionalApplication Ser. No. 61/605,143, entitled NOVEL SUTURE PASSER, which wasfiled on Feb. 29, 2012. The foregoing applications are incorporatedherein by reference as though set forth in their entirety.

TECHNICAL FIELD

The present invention relates to surgical instruments, and moreparticularly to instruments that are used to insert, pass, or retrievesurgical implants within the body.

BACKGROUND

There are a multitude of endoscopic, arthroscopic or other surgicalprocedures that require the ability to pass suture through soft tissuesas part of an effort to repair various damaged structures. Surgicalinstruments specifically designed to pass and/or retrieve suture throughtissue have become increasingly popular among surgeons. Due to the sizeconstraints of the surgical procedure, the pathway for the needle topass through the instrument and tissue is typically non-linear. Becauseof this non-linear pathway, the needle used to pass or retrieve thesuture must be flexible enough to bend, yet rigid enough to still passthrough the tissue to be sutured. Some existing needles are unable toreliably meet these requirements.

The specific mechanism by which the suture can be passed or retrievedmay be accomplished by the needle, the instrument, or a secondary suturecapturing feature such as a wire loop snare. Suture mechanisms involvingthe instrument or secondary features will add complexity to the designof the instrument and may even add steps to the surgical procedure.Mechanisms that utilize the needle for suture retrieval typically do notactively grasp the suture without assistance from other features on theinstrument.

In order to consistently pass and retrieve suture through tissue, acomplex process is involved that combines the challenges, describedabove, of passing a needle over a non-linear pathway and reliablyretrieving the suture, all while operating through a small cannula andworking in the confines of a small anatomical space.

Aside from sutures, other types of implant devices may be required to beimplanted with constraints similar to those described above. Theseimplants may need to be implanted or removed over a non-linear pathwayrelative to the access ports. Accordingly, procedures involving suchimplants are similarly difficult with existing technology.

SUMMARY

The various systems and methods of the present technology have beendeveloped in response to the present state of the art, and inparticular, in response to the problems and needs in the art that havenot yet been fully solved by currently available suture passers.

In an aspect of the technology, a suture passer system for a suturehaving a first free end, a second free end opposite the first free end,and a middle portion between the first free end and the second free endincludes: a suture passer having a proximal end, a distal end oppositethe proximal end, an intermediate portion coupled to and extendingbetween the proximal end and the distal end, and a first needle residingat least partially within the intermediate portion; wherein the distalend of the suture passer includes a suture holding feature; wherein adistal end of the first needle has a distally-sharpened first member, adistally-sharpened second member, and a channel extending between thefirst member and the second member; wherein the first needle is movablebetween a retracted position and an extended position, wherein the firstneedle resides at least partially within the intermediate portion of thesuture passer when the first needle is in the retracted position,wherein the first needle extends to the suture holding feature in thedistal end of the suture passer when the first needle is in the extendedposition; wherein the suture is transferred between the distal end ofthe suture passer and the first needle when the first needle movesbetween the retracted position and the extended position.

Embodiments may include some or all of the following characteristics.

The suture holding feature includes a slot extending across the distalend of the suture passer, wherein the suture is transferred between theslot and the channel when the first needle moves between the retractedposition and the extended position.

The first needle includes a capture hole, wherein the channel providesaccess to the capture hole; wherein the suture is transferred betweenthe slot and the capture hole when the first needle moves between theretracted position and the extended position.

The suture passer system includes a pusher component including a shaftand a distal portion extending from the shaft, the distal portionincluding at least one pushing arm; wherein the pusher component ismovable between a retracted position and an extended position, whereinthe pusher component resides at least partially within the intermediateportion of the suture passer when the pusher component is in theretracted position, wherein the pusher component extends against theslot of the distal end of the suture passer when the pusher component inthe extended position; wherein the suture is transferred from thecapture hole to the slot when the first needle is in the extendedposition and the pusher component moves between the retracted positionand the extended position.

The pusher component is biased to remain in, or to automatically moveto, the retracted position except when the pusher component is actuatedto move the pusher component distally toward the extended position.

The distal end of the suture passer includes a sharp, blade-likeextension.

The suture holding feature includes a first tab coupled to the distalend of the suture passer, wherein the suture is transferred from thechannel to the first tab when the first needle moves between theretracted position and the extended position.

The distal end of the suture passer includes a distal wall and a baseopposite the distal wall, wherein the base is coupled to theintermediate portion of the suture passer, wherein the base includes atleast one slot that receives the suture, wherein the at least one slotof the base is aligned with the channel of the first needle when thefirst needle is in the retracted position.

The distal wall includes at least one proximally-facing protrusion.

The first needle is biased to remain in, or to automatically move to,the retracted position except when the first needle is actuated to movethe first needle distally toward the extended position.

The suture passer system includes a second needle residing at leastpartially within the intermediate portion of the suture passer; whereina distal end of the second needle includes a distally-sharpened firstmember, a distally-sharpened second member, and a channel extendingbetween the first member of the second needle and the second member ofthe second needle; wherein the second needle is movable between aretracted position and an extended position, wherein the second needleresides at least partially within the intermediate portion of the suturepasser when the second needle is in the retracted position, wherein thesecond needle extends to the suture holding feature in the distal end ofthe suture passer when the second needle is in the extended position;wherein the suture is transferred between the distal end of the suturepasser and the second needle when the second needle moves between theretracted position and the extended position.

The suture holding feature includes a second tab coupled to the distalend of the suture passer, wherein the suture is transferred from thechannel of the second needle to the second tab when the second needlemoves between the retracted position and the extended position.

The suture holding feature includes a slot extending across the distalend of the suture passer, wherein the suture is transferred between theslot and the channel of the second needle when the second needle movesbetween the retracted position and the extended position.

The second needle includes a capture hole, wherein the channel of thesecond needle provides access to the capture hole of the second needle;wherein the suture is transferred between the slot and the capture holeof the second needle when the second needle moves between the retractedposition and the extended position.

In another aspect of the technology, a suture passer system for a suturehaving a first free end, a second free end opposite the first free end,and a middle portion between the first free end and the second free endincludes: a suture passer having a proximal end, a distal end oppositethe proximal end, an intermediate portion coupled to and extendingbetween the proximal end and the distal end, and a first needle residingat least partially within the intermediate portion; wherein the distalend of the suture passer has a distal wall oriented transversely to theintermediate portion, wherein the distal wall has a suture holdingfeature, wherein the distal wall terminates in a sharp, blade-likeextension; wherein the first needle is movable between a retractedposition and an extended position, wherein the first needle resides atleast partially within the intermediate portion of the suture passerwhen the first needle is in the retracted position, wherein the firstneedle extends to the suture holding feature when the first needle is inthe extended position; wherein the suture is transferred between thedistal end of the suture passer and the first needle when the firstneedle moves between the retracted position and the extended position.

Embodiments may include some or all of the following characteristics.The sharp, blade-like extension is divided into at least two portions byat least one slot. At least one side of the sharp, blade-like extensionis beveled. At least two sides of the sharp, blade-like extension arebeveled. The distal wall includes at least one proximally-facingprotrusion.

In yet another aspect of the technology, a suture passer system for asuture having a first free end, a second free end opposite the firstfree end, and a middle portion between the first free end and the secondfree end includes: a suture passer having a proximal end, a distal endopposite the proximal end, an intermediate portion coupled to andextending between the proximal end and the distal end, a first needleresiding at least partially within the intermediate portion, and a firstpusher component residing at least partially within the intermediateportion; wherein the distal end of the suture passer has a sutureholding feature; wherein the first pusher component includes at leastone pushing arm extending beside the first needle; wherein the firstneedle includes a capture hole; wherein the first needle is movablebetween a retracted position and an extended position, wherein the firstneedle resides at least partially within the intermediate portion of thesuture passer when the first needle is in the retracted position,wherein the first needle extends to the suture holding feature when thefirst needle is in the extended position; wherein the first pushercomponent is movable between a retracted position and an extendedposition, wherein the first pusher component resides at least partiallywithin the intermediate portion of the suture passer when the firstpusher component is in the retracted position, wherein the first pushercomponent extends to the suture holding feature when the first pushercomponent is in the extended position; wherein the suture is transferredfrom the capture hole of the first needle to the distal end of thesuture passer when the first needle is in the extended position and thefirst pusher component moves between the retracted position and theextended position.

Embodiments may include some or all of the following characteristics.The first pusher component is independently movable relative to thefirst needle. The first pusher component includes a shaft and a distalportion extending from the shaft, wherein the distal portion includesthe at least one pushing arm. The shaft of the first pusher componentextends beside the needle in the intermediate component of the suturepasser. The first pusher component includes at least two pushing armsextending beside the first needle. The at least two pushing arms are onopposite sides of the first needle.

In yet another aspect of the technology, a suture passer system for asuture having a first free end, a second free end opposite the firstfree end, and a middle portion between the first free end and the secondfree end includes: a suture passer having a proximal end, a distal endopposite the proximal end, an intermediate portion coupled to andextending between the proximal end and the distal end, and a firstneedle residing at least partially within the intermediate portion;wherein the distal end of the suture passer includes a distal walloriented transversely to the intermediate portion, wherein the distalwall includes a suture holding feature including a slot extending acrossthe distal wall, wherein the slot extends laterally through a side ofthe distal end of the suture passer to form a lateral alcove in thedistal end of the suture passer; wherein the first needle is movablebetween a retracted position and an extended position, wherein the firstneedle resides at least partially within the intermediate portion of thesuture passer when the first needle is in the retracted position,wherein the first needle extends to the suture holding feature when thefirst needle is in the extended position; wherein the suture istransferred between the distal end of the suture passer and the firstneedle when the first needle moves between the retracted position andthe extended position.

Embodiments may include some or all of the following characteristics. Aproximal portion of the slot extends laterally through a side of thedistal end of the suture passer to form an enlarged lateral alcove inthe distal end of the suture passer. The distal wall adjacent to thealcove extends proximally, terminating in a proximally-projecting freeend. The distal wall includes at least one proximally-facing protrusion.

In yet another aspect of the technology, a suture passer system for asuture including a first free end, a second free end opposite the firstfree end, and a middle portion between the first free end and the secondfree end includes: a suture passer including a proximal end, a distalend opposite the proximal end, an intermediate portion coupled to andextending between the proximal end and the distal end, a first needle,and a second needle, wherein the first needle and the second needlereside at least partially within the intermediate portion; wherein thedistal end of the suture passer includes a suture holding feature;wherein the first needle and the second needle each include a distal endincluding a distally-sharpened first member, a distally-sharpened secondmember, and a channel extending between the first member and the secondmember; wherein the first needle is movable between a retracted positionand an extended position, wherein the first needle resides at leastpartially within the intermediate portion of the suture passer when thefirst needle is in the retracted position, wherein the first needleextends to the suture holding feature in the distal end of the suturepasser when the first needle is in the extended position; wherein thesecond needle is movable between a retracted position and an extendedposition, wherein the second needle resides at least partially withinthe intermediate portion of the suture passer when the second needle isin the retracted position, wherein the second needle extends to thesuture holding feature in the distal end of the suture passer when thesecond needle is in the extended position; wherein the first free end ofthe suture is transferred between the distal end of the suture passerand the first needle when the first needle moves between the retractedposition and the extended position; wherein the second free end of thesuture is transferred between the distal end of the suture passer andthe second needle when the second needle moves between the retractedposition and the extended position.

Embodiments may include some or all of the following characteristics.The distal end of the suture passer includes a base coupled to theintermediate portion of the suture passer, wherein the base includes atleast one slot that receives the suture, wherein the at least one slotis aligned with a first channel when the first needle is in theretracted position, wherein the first channel is selected from the groupconsisting of the channel of the first needle and the channel of thesecond needle. The base includes a first slot and a second slot, whereinthe first slot is aligned with the channel of the first needle when thefirst needle is in the retracted position and the second slot is alignedwith the channel of the second needle when the second needle is in theretracted position. The suture holding feature includes a first tabcoupled to the distal end of the suture passer, wherein the suture istransferred from the channel of the first needle to the first tab whenthe first needle moves between the retracted position and the extendedposition. The suture holding feature includes a second tab coupled tothe distal end of the suture passer, wherein the suture is transferredfrom the channel of the second needle to the second tab when the secondneedle moves between the retracted position and the extended position.The suture holding feature includes a slot extending across the distalend of the suture passer, wherein the second needle includes a capturehole, wherein the channel of the second needle provides access to thecapture hole, wherein the suture is transferred between the slot and thecapture hole of the second needle when the second needle moves betweenthe retracted position and the extended position.

In yet another aspect of the technology, a needle for a suture passersystem includes: a proximal end including a tubular shank; a distal endopposite the proximal end; and an intermediate portion extending betweenthe proximal end and the distal end; wherein, in an undeflected state,the needle includes a uniform cross sectional shape along an entirelength of the needle, wherein the cross sectional shape extends along anonlinear pathway.

Embodiments may include some or all of the following characteristics. Adistal end of the needle includes a distally-sharpened first member, adistally-sharpened second member, and a channel extending distallybetween the first member and the second member.

The needle includes a capture hole, wherein the channel provides accessto the capture hole. The intermediate portion includes a slot extendingthrough the intermediate portion and extending between the proximal endand the distal end. The uniform cross sectional shape is selected fromthe group of cross-sectional shapes consisting of polygonal, triangular,square, rectangular, quadrilateral, parallelogram, rhombus, trapezoid,diamond-shaped, D-shaped, round, circular, oval, elliptical, and ovoid.These and other features and advantages of the present technology willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the technology as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the technology will be described in conjunctionwith the accompanying drawings. These drawings are to be construed asnon-limiting examples of the present technology; those of skill in theart will appreciate that a wide variety of modifications are possiblewithin the scope and spirit of the technology.

FIG. 1 is a perspective view of a rigid V-shaped pusher.

FIG. 2A is a perspective view of a pusher with a central slot to addflexibility.

FIG. 2B is a section view from along the length of the pusher of FIG.2A, with the selectively bendable portion having a first cross-sectionalshape selected to restrict bending perpendicular to its longitudinallength.

FIG. 2C is a section view from along the length of the pusher of FIG.2A, with the selectively bendable portion having a secondcross-sectional shape selected to facilitate bending in the transversedirection.

FIG. 2D is a section view from along the length of the pusher of FIG.2A, with the selectively bendable portion having a third cross-sectionalshape selected to facilitate bending in the lateral direction.

FIGS. 3A-3C are end, side and top views of a rigid needle with a suturecapture feature at one end.

FIGS. 4A-4C are end, side and top views of a needle with a central slotthrough the middle and a suture capture feature at one end.

FIGS. 5A-5H are end views of alternative implant manipulators showvarying cross-sectional shapes including U-shaped and V-shapedcross-sections.

FIGS. 6A-6C are end views of alternative implant manipulatorsillustrating how the cross-sectional shape of the needle may be alteredover a wide range of angles.

FIG. 7A is a top view of the distal end of the needle of FIGS. 3A-3Cillustrating the suture capture feature of the needle in greater detail.

FIG. 7B is a top view of the distal end of a needle with a suturecapture feature according to another alternative embodiment of theinvention.

FIG. 8 is a perspective view of the needle of FIGS. 4A-4C with theneedle bent in a downward direction.

FIG. 9 is a perspective view of the needle of FIGS. 4A-4C with theneedle bent to the right.

FIGS. 10A-10B are top views of the needle of FIG. 7B illustrating howthe suture capture slot may be forced open via non-planar spreading ofthe first and second members.

FIGS. 11A-11B are end views of the needle of FIG. 7B illustrating howthe suture capture slot may be forced open via lateral compression ofthe sides.

FIG. 12 is a side elevation view of a suture passer with a pair oftissue grasping jaws and a needle that passes from the bottom jaw to thetop jaw.

FIG. 13A is side elevation, section view of the lower jaw of theinstrument of FIG. 12 demonstrating how the bore of the lower jaw variesin cross-sectional shape.

FIG. 13B is a top view of the lower jaw of the instrument illustratingthe V-shaped cross-sectional shape of the bore at the distal tip toaccommodate the needle.

FIG. 14A is a section view of the bore of FIG. 13B.

FIG. 14B is another section view of the bore of FIG. 13B.

FIG. 14C is another section view of the bore of FIG. 13B.

FIG. 15 is a side elevation view of a suture passer with a pair oftissue grasping jaws with a needle that passes from the top jaw to thebottom jaw.

FIG. 16A is a side elevation, section view of a sliding tip of a suturepasser according to an alternative embodiment of the invention.

FIG. 16B is a perspective view of the underside of the sliding tip ofFIG. 16A.

FIG. 17 is a side elevation view showing the distal end of the top jawwith the sliding tip in an extended position with the needle in aninitial straight configuration.

FIGS. 18A-18B are side elevation and bottom views of the distal end ofthe top jaw with the sliding tip in a retracted position with the needlebent downward.

FIG. 19 is a side elevation view of a cartridge tip that may be slidablyinserted into the distal end of an instrument according to analternative embodiment of the invention.

FIG. 20 is a side elevation view showing how the needle may be suppliedpre-loaded into the cartridge.

FIG. 21A is a side elevation view of the distal end of an instrumentshowing how the proximal end of the needle can be inserted into theinstrument followed by the cartridge to complete the assembly.

FIG. 21B is a side elevation view of the distal end of the instrumentshowing the final assembly of the cartridge into the lower jaw.

FIG. 22 is a side elevation view of a suture passer with a single jaw.

FIG. 23A is a perspective view showing the distal end of the instrumentof FIG. 22 with the jaw in a first position.

FIG. 23B is a perspective view showing the distal end of the instrumentof FIG. 22 with the jaw in a second position.

FIG. 24 is a side elevation view of the distal end of the instrument ofFIG. 22 with the distal end positioned adjacent to a piece of tissue tobe sutured.

FIG. 25 is a side elevation view of the distal end of the instrument ofFIG. 22 showing the needle passing through the tissue and into the jaw.

FIG. 26 is a perspective view of the jaw of the suture passer of FIG.22.

FIG. 27 is a perspective view of the jaw of the suture passer of FIG. 22with the suture temporarily captured within the jaw.

FIG. 28 is a side elevation view of the distal end of the suture passerof FIG. 22 showing retraction of the needle back through the tissue toretrieve the suture.

FIG. 29 is a side elevation view of a distal end of a suture passeraccording to an alternative embodiment of the invention, showingemergence of the needle at a non-parallel angle to the intermediateportion of the instrument.

FIG. 30 is a side elevation, section view of an intermediate portion ofan instrument according to an alternative embodiment of the invention,illustrating how the needle may be bent such that it exits theintermediate portion of the instrument proximally of the distal end.

FIG. 31 is a perspective view showing a suture passer with analternative proximal end.

FIG. 32 is a side elevation view showing the distal end of a suturepasser according to another alternative embodiment of the invention,with a proximal jaw that can be used to grasp the tissue prior tosuture/needle passing.

FIGS. 33A-33C are side elevation views of a distal end of a suturepasser according to another alternative embodiment of the invention,showing how the two opposing needles may be used to pass suture back andforth between the top and bottom jaws.

FIG. 34 is a perspective view showing how the pusher of FIGS. 2A-2D maybe used to push implants or other devices along a curved pathway.

FIGS. 35A-35B are side elevation views showing how a pusher and a hollowshaft of an instrument according to an alternative embodiment may beused to insert a bone anchor into a bony surface along a nonlinearpathway.

FIG. 36A is a side view of a human knee joint in an extended position.

FIG. 36B is a perspective view of a human knee joint in a flexedposition.

FIG. 37 is a perspective view of another suture passer.

FIG. 38 is a perspective detail view of a distal tip portion of thesuture passer of FIG. 37, a suture, and a tissue portion, with a needleof the suture passer in a partially retracted position.

FIG. 39 is a perspective detail view of the distal tip portion of thesuture passer, the suture, and the tissue portion of FIG. 38, with theneedle of the suture passer in an extended position passing through thetissue portion.

FIG. 40 is a perspective detail view of the distal tip portion of thesuture passer, the suture, and the tissue portion of FIG. 38, with theneedle of the suture passer in the partially retracted position, thesuture passing through the tissue portion.

FIG. 41A is a perspective view of the distal tip portion of the suturepasser of FIG. 37.

FIG. 41B is a perspective view of another distal tip portion for asuture passer.

FIG. 42A is a perspective view of the needle of the suture passer ofFIG. 37.

FIG. 42B is a perspective view of another needle for a suture passer.

FIG. 43 is a perspective view of yet another needle for a suture passer.

FIG. 44 is a perspective view of a distal tip portion of yet anothersuture passer, with a first needle of the suture passer in a partiallyretracted position and a second needle of the suture passer in apartially extended position.

FIG. 45 is a perspective view of the distal portion of the suture passerof FIG. 44 with a suture.

FIG. 46 is a perspective view of the distal portion of the suture passerof FIG. 44 with the first needle in a partially extended position, thesuture carried by the first needle.

FIG. 47 is a perspective view of a portion of the distal portion of thesuture passer of FIG. 44, showing a suture capture mechanism.

FIG. 48 is a perspective view of a distal tip portion of yet anothersuture passer, with a needle of the suture passer in a partiallyextended position, a suture carried by the needle.

FIG. 49 is a perspective view of the distal tip portion of the suturepasser of FIG. 48, with the needle of the suture passer in an extendedposition, with pushing arms of the suture passer in an extendedposition.

FIG. 50 is a perspective view of the distal tip portion of the suturepasser of FIG. 48, with the needle in a partially retracted position,the suture carried by the distal tip portion.

FIG. 51 is a perspective view of the distal tip portion of the suturepasser of FIG. 48, with the needle in the partially retracted position,the suture carried by the needle.

FIG. 52 is an exploded perspective view of a prior art needle assemblyfor a suture passer, with a needle and a shaft.

FIG. 53A is a side view of yet another needle for a suture passer.

FIG. 53B is a bottom view of the needle of FIG. 53A.

FIG. 53C is a perspective view of the needle of FIG. 53A.

FIG. 53D is another perspective view of the needle of FIG. 53A from adifferent angle.

FIG. 54A is a perspective view of another needle assembly for a suturepasser, with a needle tip and a needle shaft.

FIG. 54B is a perspective view of a distal tip portion of the needleassembly of FIG. 54A.

FIG. 55A is a perspective view of yet another needle assembly for asuture passer, with a needle and a spine.

FIG. 55B is an end view of the needle assembly of FIG. 55A.

FIG. 56 is a perspective view of the distal tip portion of yet anothersuture passer, with a needle of the suture passer in a partiallyextended position.

FIG. 57 is another perspective view of the distal tip portion of thesuture passer of FIG. 56, from a different viewpoint.

FIG. 58 is yet another perspective view of the distal tip portion of thesuture passer of FIG. 56, from another different viewpoint.

DETAILED DESCRIPTION

The presently preferred embodiments of the present invention will bebest understood by reference to the drawings, wherein like parts aredesignated by like numerals throughout. It will be readily understoodthat the components of the present invention, as generally described andillustrated in the Figures herein, could be arranged and designed in awide variety of different configurations. Thus, the following moredetailed description of the embodiments of the apparatus, system, andmethod of the present invention, as represented in FIGS. 1 through 58,is not intended to limit the scope of the invention, as claimed, but ismerely representative of presently preferred embodiments of theinvention.

Referring to FIG. 1, a perspective view illustrates an implantmanipulator 100 according to one embodiment of the invention. Theimplant manipulator 100 of FIG. 1 may take the form of a pusher 100designed to push a surgical implant (not shown) into a desired locationwithin the tissues of a body. Other implant manipulator types will bedisclosed on connection with other figures. The pusher 100 may have alongitudinal direction 102, a lateral direction 104, and a transversedirection 106. The longitudinal direction 102 is parallel to the length,i.e., the long axis, of the pusher 100. The directions 104, 106 areorthogonal to it.

The pusher 100 may have a proximal end 110, distal end 112, and anintermediate portion 114 that extends between the proximal and distalends 110, 112. Each end 110, 112 of the pusher 100 may take on a bluntor flat profile. Alternatively, the proximal end 110 may have a grippinginterface (not shown) such as a handle or the like, and/or the distalend 112 may have an implant interface (not shown) designed to retain animplant until it has reached its desired location. The pusher 100 may beused to place an implant within a body, reposition an implant within abody, and/or remove an implant from the body.

The cross-sectional shape of the pusher 100 may be generally V-shaped.As best seen at the distal end 112 in FIG. 1, the cross-sectional shapemay have a first arm 120, a second arm 122, and a spine 124. The firstand second arms 120, 122 may be connected to the spine 124, and asillustrated in FIG. 1, they may be unitarily formed with the spine. Thecross-sectional shape may be uniform along the entire length of thepusher 100. The first and second arms 120, 122 may extend from the spine124 to define a perpendicular or near-perpendicular angle between thefirst and second arms 120, 122.

This cross-sectional shape, including the dimensions of its variousparts, may result in a structure that has a high “flexural rigidity”relative to bending perpendicular to its long axis, as compared withother cross-sectional shapes such as rectangular or round profiles ofsimilar material volume. Beneficially, the implant manipulator 100 has arelatively low profile. The “profile” of a medical instrument generallyrefers to the amount of tissue it must displace as it moves through thebody. Tissue displacement leads to post-operative discomfort or pain andlengthens recovery time; hence, it is desirable for medical instrumentsto be “low profile.” The profile of an instrument is generallyproportional to the area of the cross-sectional shape that mustpenetrate the tissue; in the case of a hollow cross-sectional shape suchas a tube, the profile is generally proportional to the area of theshape plus the area of the interior space within the shape.

An implant manipulator like the pusher 100 may optionally be actuated byan actuator (not shown) that helps to control its motion. Such anactuator may take a variety of forms, including a suture passer, ameniscal repair device, a bone anchor placement instrument, or the like.The pusher 100 may be any instrument that moves a surgical implant to orfrom a desired location in a body, and the actuator may thus be anyinstrument that moves the implant manipulator to facilitate such motion.The actuator may be held by a user, a robotic surgical assembly, or astationary framework, and may move the implant manipulator throughmanual control with or without intervening mechanical components.Alternatively, such an actuator may use electric motors or other motionsources to move the implant manipulator.

Referring to FIG. 2A, a perspective view illustrates an implantmanipulator 200 according to an alternative embodiment of the invention.The implant manipulator 200 may also be a pusher 200. The pusher 200 maybe flexible; i.e., designed to bend in a direction perpendicular to itslong axis. Such bending may allow the pusher 200 to deflect, forexample, subcutaneously, to reach a target area along a non-linearsubcutaneous pathway. If desired, the pusher 200 may be made of asuperelastic material, i.e., a material designed to undergo relativelylarge elastic deformation, and then return to its original shape.Further, the pusher 200 may be formed of a shape memory alloy or thelike. According to one example, the pusher 200 (and other implantmanipulators embodied herein) may be made of Nitinol.

Like the pusher 100, the pusher 200 may have a proximal end 210, adistal end 212, and an intermediate portion 214. At the distal end 212,the pusher 100 has a cross-sectional shape with a first arm 220 and asecond arm 222, both of which are connected to a spine 224. The pusher200 may have the same cross-sectional shape at the proximal end 210.However, the pusher 200 may have an intermediate portion 214 that isdifferent from the intermediate portion 114 because the intermediateportion 214 may have a selectively bendable portion 230 at which theintermediate portion 214 is designed to bend. The selectively bendableportion 230 may be configured such that, in a first configuration, theselectively bendable portion 230 is substantially rigid, while in asecond configuration, the selectively bendable portion 230 is able tobend more freely. “Selective” bending refers to deliberate, controllablebending, as opposed to bending that simply occurs as an unintendedconsequence of the use of an instrument.

This configuration change may occur in many different ways. Somematerials are known to change elasticity when raised or lowered beyondcertain transition temperatures. Alternatively, stiffening members (notshown) may be inserted into engagement with a needle along the needleaxis to provide stiffening where, and when, it is desired. All suchconfiguration changes fall within the scope of the present invention.However, in the embodiment of FIG. 2A, selective bending is carried outby changing the cross-sectional shape of the selectively bendableportion 230. More precisely, an object with a given cross-sectionalshape and material composition will have a given “flexural rigidity,” orresistance to bending. Generally, positioning material further from thegeometric center of a cross-sectional shape will increase its flexuralrigidity, at least as applied to bending parallel to the direction inwhich it is displaced from the geometric center. Thus, a tube made of agiven material will tend to resist bending more effectively in alldirections perpendicular to the tube axis than a cylinder made from thesame material, with the same length.

The pusher 200 uses this principle to obtain additional stiffness whendesired, and also to exhibit additional flexure when desired. Insurgical applications, this is useful in a wide variety of contextsbecause it is very common to access a desired location within a body(such as a human body) along a nonlinear pathway, for example, to getaround intervening bones or sensitive tissues, or to provide a desiredangle of approach to the desired location. The nonlinear pathway mayrequire that instruments bend to reach the desired location. However, itmay be desirable for the instruments to retain significant stiffness toenable them to perform their intended functions at the desired location.

One example of an instrument that may need to move along a non-linearpathway is a needle for a suture passer. Such needles commonly are usedto puncture tissue and either push or pull suture through the puncturealong a direction nonparallel to the axis of the instrument.Unfortunately, prior art suture passers tend to exhibit a variety ofproblems related to the stiffness of the needle. A needle with theflexibility required to navigate the nonlinear pathway may not havesufficient rigidity to puncture the tissue without skiving against thetissue or otherwise deflecting from its intended approach vector.

The pusher 200 remedies these shortcomings through variation of thecross-sectional shape of the selectively bendable portion 230. Theselectively bendable portion 230 has a cross-sectional shape designed topermit selective flexure of the selectively bendable portion 230. Moreprecisely, the pusher 200 may have a slot 240 that interrupts the spine224 along a given length of the intermediate portion 214 such that thespine 224 exists proximate the proximal and distal ends 210, 212, butthe slot 240 is instead present in the selectively bendable portion 230.The slot 240 may be cut or otherwise removed from a full-length spinelike the spine 124 of FIG. 1, or the pusher 200 may be formed with thespine 224 and the slot 240 in place.

The slot 240 permits the selectively bendable portion 230 to bere-configured during use by changing its cross-sectional shape tocontrol its flexural rigidity, particularly as applied to bending alongthe lateral direction 104 and the transverse direction 106. Theselectively bendable portion 230 may have one flexural rigidity thatapplies to bending in the lateral direction 104, and a differentflexural rigidity that applies to bending in the transverse direction106.

The cross-sectional shape of the pusher 100 of FIG. 1 may be designed torestrict flexure of the pusher 100. The slot 240 may effectively removethe spine 224 from the cross-sectional shape of the selectively bendableportion 230, thereby allowing the arms 220, 222 to bend, rotate, ordeform in a manner that resembles the flexure that would be obtained ifthey were individual thin, flat, rectangular sections of material. Thus,the selectively bendable portion 230 may provide the flexibility toallow the pusher 200 to bend as shown in the examples in FIGS. 8 and 9.This concept will be shown and described in connection with FIGS. 2B-2D.

Referring to FIG. 2B, a section view perpendicular to the longitudinaldirection 102 illustrates the cross-sectional shape of the selectivelybendable portion 230 as configured in FIG. 2A. The selectively bendableportion 230 is configured to resist bending in the lateral andtransverse directions 104, 106. The arms 220, 222 are positioned at anangle 242 relative to each other; this angle 242 may be near 90°. Inalternative embodiments, in the rest (i.e., substantially undeflected)configuration, the arms 220, 222 may be angled relative to each other atother angles, such as 60° or 120°, or angles in between, as will beshown and described subsequently.

As mentioned previously, the flexural rigidity of a shape is generallyproportional to the distance of the material from the center of a shape.Thus, a long, flat cross-sectional shape would tend to allow easybending perpendicular to the length of the cross-sectional shape, butresist bending parallel to the length of the cross-sectional shape. Eachof the arms 220, 222 provides a relatively long, flat cross-sectionalshape, but since they are orthogonal to each other, the cross-sectionalshape of FIG. 2B is not generally parallel to any direction. Thus, theflexural rigidity is relatively high for any bending directionperpendicular to the longitudinal direction 102 (i.e., the lateraldirection 104, the transverse direction 106, or any direction that is avector with lateral and longitudinal components).

Referring to FIG. 2C, a section view perpendicular to the longitudinaldirection 102 illustrates the cross-sectional shape of the selectivelybendable portion 230 with the selectively bendable portion 230configured to resist bending in the lateral direction 104, but permitbending relatively easily in the transverse direction 106. The arms 220,222 are generally coplanar to each other. Accordingly, they are orientedat an angle 244 relative to each other of approximately 180°. As shown,the angle 244 need not be exactly 180° to facilitate bending in thetransverse direction 106. The angle 244 may, for example, be 150°, 160°,170°, 175°, or 180°. Depending on the nature of the force that moves thecross-sectional shape into the configuration shown in FIG. 2C, the angle244 may even be larger than 180°.

Referring to FIG. 2D, a section view perpendicular to the longitudinaldirection 102 illustrates the cross-sectional shape of the selectivelybendable portion 230 with the selectively bendable portion 230configured to resist bending in the transverse direction 106, but permitbending relatively easily in the lateral direction 104. The arms 220,222 are generally non-coplanar to each other, but they are generallyparallel to each other. Accordingly, they are oriented at an angle 246relative to each other of approximately 0°. As shown, the angle 246 neednot be exactly 0° to facilitate bending in the lateral direction 104.The angle 246 may, for example, be 30°, 20°, 10°, 5°, or 0°.

As a variation of the pusher 200 shown in FIGS. 2A-2D, the slot 240 mayfully extend through to the distal end 212 or the proximal end 210 ofthe pusher 200. At least one end 210 or 212 of the pusher 200 mayadvantageously maintain a length of the spine 224 so that the pusher 200has rigidity at one end 210 or 212. Rigidity at the proximal end 210 maybe beneficial if the pusher 200 is being pushed proximal to distal by aninstrument, while rigidity at the distal end 212 may be beneficial ifthe pusher 200 is being pushed against an implant or other device thatneeds to be advanced.

As another alternative, a slot may be shaped differently from the slot240 shown in FIG. 2A. In alternative embodiments (not shown), such aslot may follow a curved or jagged pathway. Multiple slots may be used,and may be parallel or co-linear and broken by intervening lengths of aspine. As yet another alternative, the feature that facilitates bendingneed not be a slot, but may simply be a notch extending along the lengthof the intermediate portion of the implant manipulator (not shown). Sucha notch may act a as a “living hinge” or “flexural hinge” by providingenhanced flexure without extending fully through the material of theimplant manipulator. As another alternative, an implant manipulator (notshown) may have an actual hinge, i.e., an interface between opposingsides that permits relative rotation between the two sides, therebyallowing the sides to collapse together and/or spread apart. As yetanother alternative, an implant manipulator (not shown) may have a stripof a secondary material with lower flexural rigidity than the materialof which the remainder of the implant manipulator is formed. All suchalternatives are contemplated within the scope of the invention and mayprovide a cross-sectional change that restricts or facilitates bendingof a selectively bendable portion, as desired.

Referring to FIGS. 3A-3C, the pusher 100 in FIG. 1 may be modified asshown in FIGS. 3A-3C to take on the configuration of an implantmanipulator 300 in the form of a needle 300. Like the pusher 100, theneedle 300 may be generally rigid, and may have a proximal end 310, adistal end 312, and an intermediate portion 314. The needle 300 may havethe same V-shaped cross-sectional shape as the pusher 100. Thus, theneedle 300 may have a cross-sectional shape with a first arm 320, asecond arm 322, and a spine 324. The distal end 312 may be designed topenetrate tissue.

More specifically, the distal end 312 may have a sharpened tip such thatit can be easily passed through tissue with minimal resistance to reduceany trauma to the body. As shown in FIGS. 3A-3C, the distal end 312 mayhave a first member 350 and a second member 352, each of which has asharpened tip 354. The distal end 312 may also have an implant interface360 designed to move an implant within the body in a desired manner. An“implant interface” includes any feature that abuts an implant (i.e.,contacts the implant) in order to guide the implant in some manner.Thus, an implant interface may retain an implant, or it may simply pushor otherwise drive it to the desired location. The desired location maybe an implantation location within the body, or in the case of animplant to be removed, a location outside the body.

In the embodiment of FIGS. 3A-3C, the implant interface 360 may take theform of a suture capture feature 360. A suture capture feature includesany feature that retains a length of suture to enable the length ofsuture to be moved. Thus, in this configuration, the needle 300 may beused to penetrate through a section of tissue, capture a section ofsuture material in the suture capture feature 360, and then retrieve thesuture material back through the tissue via withdrawal of the needle300. This can be beneficial when it is necessary to pass suture throughtissue in a controlled manner without multiple instruments or featuresrequired for passing and retrieving the suture. The operation of thesuture capture feature 360 will be shown and described in greater detailin connection with FIG. 7A.

Referring to FIGS. 4A-4C, the needle 300 of FIGS. 3A-3C, may be furthermodified to provide an implant manipulator 400 according to anotherembodiment of the invention. The implant manipulator 400 may take theform of a needle 400 with features that are generally similar to thoseof the needle 300. However, the needle 400 may have an intermediateportion 414 that is different from the intermediate portion 314 becausethe intermediate portion 414 may have a selectively bendable portion 430at which the intermediate portion 414 is designed to bend. Theselectively bendable portion 430 may be configured such that, in a firstconfiguration, the selectively bendable portion 430 is substantiallyrigid, while in a second configuration, the selectively bendable portion430 is able to bend more freely. More precisely, the spine 424 of theneedle 400 may be interrupted by a slot 440 that generally traverses theintermediate portion 414 in a manner similar to that of the slot 240 ofFIGS. 2A-2D. The slot 440 may enable the cross-sectional shape of theselectively bendable portion 430 to vary as in FIGS. 2B-2D toselectively facilitate bending parallel to the lateral direction 104and/or the transverse direction 106.

As with the pusher 200 of FIGS. 2A-2D, the needle 400 may be configuredin a wide variety of ways. Such variations include variations of theslot 240 and other features used in place of the slot to providecross-sectional change.

Advantageously, implant manipulators according to some embodiments ofthe invention may have a cross-sectional shape, perpendicular to thelength of the implant manipulator that extends along a nonlinearpathway. A shape that extends along a pathway has a relativelyconsistent width perpendicular to a linear or nonlinear form embeddedwithin the shape such that the form defines a pathway. The pathwayextends through the center of the shape to bisect the width at eachpoint along its length. A shape that extends along a pathway need nothave a precisely constant width perpendicular to the pathway; rather,some variation is to be expected, particularly at the end points and anytight turns in the pathway.

In one example, a cross-sectional shape may have a width that neverexceeds 200% of its average width perpendicular to the pathway.According to another example, a cross-sectional shape may have a widththat never exceeds 150% of its average width perpendicular to thepathway. According to yet another example, a cross-sectional shape mayhave a width that never exceeds 125% of its average width perpendicularto the pathway.

“Nonlinear” refers to a shape, at least part of which is not a straightline. Thus, a nonlinear shape may have a straight portion and a portionwith a curve, vertex, or other departure from the straight line. Theseconcepts will be shown and described in connection with FIGS. 5A and 5B.

Referring to FIGS. 5A and 5B, end views illustrate some of thecross-sectional shapes that may be used for an implant manipulator. Moreprecisely, FIG. 5A illustrates an implant manipulator 500 having aV-shaped cross-sectional shape similar to the implant manipulators ofFIGS. 1-4C. The implant manipulator 500 may have a first arm 520 and asecond arm 522. The first arm 520 and the second arm 522 may beconnected together via a spine 524. The result may be a V-shape, whichis upside-down in FIG. 5A.

A “V-shape” includes any shape with only two arms that join to define avertex (or region with a small radius of curvature defining anear-vertex), leaving an open space, such as the space 526, between thearms with unrestricted access to the space from outside thecross-sectional shape. Thus, if the first arm 520 and second arm 522were modified such that they curve or angle toward each other on theopposite side of the space 526 from the spine 524, the resultingcross-sectional shape (not shown) would not be a V-shape, but mayinstead be a C-shape (if the arms do not connect together) or an O-shape(if the arms do connect together). The arms of a V-shapedcross-sectional shape may be straight or curved. Additionally, the angleat the vertex need not be a right angle, as shown in FIG. 5A, but may beany of a wide variety of angles that will be shown and described inconnection with FIGS. 6A-6C.

More particularly, the cross-sectional shape of the selectively bendableportion 530 (FIG. 6B) may extend along a nonlinear pathway 532. Asshown, the nonlinear pathway 532 extends from the outermost tip of thefirst arm 520 to the outermost tip of the second arm 522. The nonlinearpathway 532 defines a pathway within the definition provided abovebecause the cross-sectional shape of the selectively bendable portion530 has a relatively consistent width perpendicular to the nonlinearpathway 532.

The nonlinear pathway 532 has a width 534 within the main portion of thefirst arm 520 and the second arm 522. The nonlinear pathway 532 also hasa width 536 across the spine 524. Additionally, the nonlinear pathway532 has a width 538 toward the outermost ends of the first arm 520 andthe second arm 522. The width 536 may be larger than the width 534, andthe width 534 may be larger than the width 538, which tapers to zero atthe ends of the nonlinear pathway 532. However, the width of thecross-sectional shape is still relatively consistent along the length ofthe nonlinear pathway 532 despite these differences. In otherembodiments (not shown), one or more of the first arm 520, the secondarm 522, and the spine 524 may have a taper, a bump, recess, or otherirregularity; such irregularities may change the shape of the nonlinearpathway 532, but unless they are extreme, they do not keep thecross-sectional shape from being one that follows a pathway.

The nonlinear pathway 532 has linear segments within the first arm 520and the second arm 522, but has a small radius of curvature (e.g., anear-vertex as described above) through the spine 524. Thus, thenonlinear pathway 532 is nonlinear and is also V-shaped within thedefinition provided above. In alternative embodiments, a nonlinearpathway like the nonlinear pathway 532 may be broken by one or morefeatures such as the slot 240 of FIGS. 2A-2D. A “break” in a pathway maybe defined as a location at which the material at the pathway isinterrupted, but the pathway is still readily discernible. For example,the cross-section shown in FIG. 2B still presents a readily discernibleV-shaped nonlinear pathway, despite the presence of the break defined bythe intersection of the slot 240 with the cross-sectional shape.

In operation, the implant manipulator 500 may function in the mannerillustrated in FIGS. 2B-2D. The V-shape may bend at or near the spine524 to bring the first arm 520 and the second arm 522 close to acoplanar condition as in FIG. 2C, or may bend the other way to bring thefirst arm 520 and the second arm 522 close to a parallel condition as inFIG. 2D. Thus, the V-shape may be altered to facilitate or restrictbending as desired.

Referring to FIG. 5B, an end view illustrates an implant manipulator 550according to one alternative embodiment of the invention. The implantmanipulator 550 may have an arcuate or U-shaped cross-sectional shape.More precisely, the implant manipulator 550 may have a first arm 570 anda second arm 572 that are connected together via a spine 574. The firstarm 570 and the second arm 572 are both curved, and share the sameradius of curvature 590. The spine 574 does not form a vertex like thespine 524 of FIG. 5A, but rather represents a continuous transitionbetween the first arm 570 and the second arm 572. In FIG. 5B, the spine574 preserves the radius of curvature of the first arm 570 and thesecond arm 572, although this need not be the case with other U-shapedcross-sectional shapes.

Generally, a “U-shape” includes any shape with only two arms that joinat a radius to define a round in place of the vertex of a V-shape,leaving an open space, such as the space 576, between the arms withunrestricted access to the space from outside the cross-sectional shape.A U-shape may have arms that are straight or curved.

The cross-sectional shape of the selectively bendable portion 580 mayextend along a nonlinear pathway 582. As shown, the nonlinear pathway582 extends from the outermost tip of the first arm 570 to the outermosttip of the second arm 572. The nonlinear pathway 582 defines a pathwaywithin the definition provided above because the cross-sectional shapeof the selectively bendable portion 580 has a relatively consistentwidth perpendicular to the nonlinear pathway 582.

The nonlinear pathway 582 has a width 584 within the main portion of thefirst arm 570, the second arm 572, and the spine 574. Additionally, thenonlinear pathway 582 has a width 588 toward the outermost ends of thefirst arm 570 and the second arm 572. The width 584 may be larger thanthe width 588, which tapers to zero at the ends of the nonlinear pathway582. However, the width of the cross-sectional shape is still relativelyconsistent along the length of the nonlinear pathway 582 despite thesedifferences. In other embodiments (not shown), one or more of the firstarm 570, the second arm 572, and the spine 574 may have a taper, a bump,recess, or other irregularity; such irregularities may change the shapeof the nonlinear pathway 582, but unless they are extreme, they do notkeep the cross-sectional shape from being one that follows a pathway.

The nonlinear pathway 582 has no linear segments, but rather has aconstant radius of curvature 590 through the first arm 570, the secondarm 572, and the spine 574. The first arm 570 and the second arm 572join at the spine, 574, and all of them share the same radius ofcurvature 590. Since the spine 574 has a relatively large radius, thenonlinear pathway 582 is nonlinear and is also U-shaped within thedefinition provided above.

In operation, the implant manipulator 550 may function in a mannersomewhat similar to that of FIGS. 2B-2D. More precisely, as shown inFIG. 5B, the implant manipulator 550 may generally resist bending alongthe lateral direction 104 or the transverse direction 106 because thecross-sectional shape in FIG. 5B has significant mass displaced from itsgeometric center along both directions. However, if the first arm 570and the second arm 572 were to be splayed outward so that the radius ofcurvature 590 is effectively increased (analogous to FIG. 2C), theflexural rigidity of the implant manipulator 550 with reference tobending along the transverse direction 106 would be effectivelydecreased, while the flexural rigidity for bending along the lateraldirection 104 would be increased. If desired, the cross-sectional shapeof the implant manipulator 550 may even flex sufficiently that thenonlinear pathway 582 extends in a substantially straight line.

If the first arm 570 and the second arm 572 were to be urged together sothat the radius of curvature 590 is effectively decreased (analogous toFIG. 2D), the flexural rigidity of the implant manipulator 550 withreference to bending along the lateral direction 104 would beeffectively decreased, while flexural rigidity for bending along thetransverse direction 106 would be decreased. If desired, thecross-sectional shape of the implant manipulator 550 may flex such thatthe radius of curvature 590 becomes variable along the length of thenonlinear pathway 582. For example, the spine 574 may experience greaterdeflection than the second arm 572 and the spine 574 so that, at thespine 574, the radius of curvature is smaller than at the first arm 570and the second arm 572. If desired, the cross-sectional shape of theimplant manipulator 550 may vary sufficiently that the ends of first arm570 and the second arm 572 come into contact with each other.

In alternative embodiments (not shown), an implant manipulator may havea U-shaped cross-sectional shape like the implant manipulator 550 ofFIG. 5B in combination with other features disclosed in connection withother embodiments herein. For example, such an implant manipulator mayhave a slot like the slot 240 of FIGS. 2A-2D, an implant interface 360like that of FIGS. 3A-3C, or the like. Alternatively, such an implantmanipulator may have other features that facilitate change of itscross-sectional shape. For example, such an implant manipulator may havea differently-shaped slot, a groove or other recess that does not extendfully through its spine, a region of more flexible material (forexample, at the spine), or any other change disclosed elsewhere in thisspecification.

Referring to FIG. 5C, an end view illustrates an implant manipulator 592according to another embodiment of the invention. The implantmanipulator 592 may be similar to the implant manipulator 500 of FIG.5A, except that the corners and edges of the implant manipulator 592 aresquared rather than rounded. Such squared edges may facilitate tissuepuncturing and/or penetration. The use of squared or rounded edges maydepend on the desired tissue penetration characteristics of the implantmanipulator.

Referring to FIG. 5D, an end view illustrates an implant manipulator 593according to another alternative embodiment of the invention. Theimplant manipulator 593 may be similar to that of FIG. 5A, but withshorter arms. The arms of an implant manipulator may be shortened orlengthened to obtain the desired bending and/or tissue penetrationcharacteristics.

Referring to FIG. 5E, an end view illustrates an implant manipulator 594according to another alternative embodiment of the invention. Theimplant manipulator 594 may be similar to that of FIG. 5A, but with armsof unequal length. Such a configuration may further provide a desiredset of bending and/or tissue penetration characteristics.

Referring to FIG. 5F, an end view illustrates an implant manipulator 595according to another alternative embodiment of the invention. Theimplant manipulator 595 may have an elongated spine between shorterarms. The arms and/or spine may flex to selectively restrict orfacilitate bending. Such a configuration may further provide a desiredset of bending and/or tissue penetration characteristics.

Referring to FIG. 5G, an end view illustrates an implant manipulator 596according to another alternative embodiment of the invention. Theimplant manipulator 596 may have a spine with a relatively large radiusof curvature, with arms that extend from the spine generally parallel toeach other. Like the spine 574 of the implant manipulator 550 of FIG.5B, the spine of the implant manipulator 596 may flex via variation ofits center of curvature. The result of such flexure may be alteration ofthe relative orientations of the arms, thereby selectively facilitatingor restricting bending.

Referring to FIG. 5H, an end view illustrates an implant manipulator 597according to another alternative embodiment of the invention. Theimplant manipulator 597 may be similar to the implant manipulator 550 ofFIG. 5B, but with a larger radius of curvature. Such a configuration mayfurther provide a desired set of bending and/or tissue penetrationcharacteristics.

The V-shaped nonlinear pathway 532 and the U-shaped nonlinear pathway582 of FIGS. 5A and 5B, and the nonlinear pathways of FIGS. 5C-5H aremerely exemplary; a wide variety of alternative cross-sectional shapesmay be used within the scope of the present invention. For example, inalternative embodiments (not shown), a selectively flexible portion ofan implant manipulator may have a C-shaped, D-shaped, H-shaped,I-shaped, J-shaped, K-shaped, L-shaped, M-shaped, N-shaped, O-shaped,S-shaped, T-shaped, W-shaped, X-shaped, Y-shaped, or Z-shapedcross-section extending along the corresponding nonlinear pathway. Suchcross-sectional shapes may also be variable between differentconfigurations to provide a selectively bendable portion, the flexuralrigidity of which can be controlled through variation of thecross-sectional shape.

Referring to FIGS. 6A-6C, end views illustrate how the angulation of theV-shaped cross-section can vary to alter the stiffness and profile ofthe device. More specifically, FIG. 6A illustrates an implantmanipulator 600 according to one alternative embodiment, FIG. 6Billustrates the implant manipulator 500 of FIG. 5A, and FIG. 6Cillustrates an implant manipulator 650 according to another alternativeembodiment of the invention.

Referring to FIG. 6A, an end view illustrates the implant manipulator600. The implant manipulator 600 may have a first arm 620 and a secondarm 622 that are joined at a spine 624 to define a V-shapedcross-sectional shape, as described in connection with FIG. 5A. Theimplant manipulator 600 may have a selectively bendable portion 630having the cross-sectional shape shown in FIG. 6A. In its generallyunaltered (i.e., undeflected) state, the cross-sectional shape may havean angle 640 between the first arm 620 and the second arm 622. As shownin FIG. 6A, the angle 640 may be an obtuse angle, i.e., an angle greaterthan 90°. The angle 640 may fall within the range of 90° to 150°. Moreparticularly, the angle 640 may fall within the range of 100° to 140°.Yet more particularly, the angle 640 may fall within the range of 110°to 130°. Still more particularly, the angle 640 may be 120°.

Referring to FIG. 6B, an end view illustrates the implant manipulator500. The various features of the implant manipulator 500 are describedin connection with FIG. 5A. As shown in FIG. 6B, the cross-sectionalshape of the implant manipulator 500 may have an angle 540 between thefirst arm 520 and the second arm 522, in its unaltered state. The angle540 may be a right angle, i.e., a 90° angle.

Referring to FIG. 6C, an end view illustrates the implant manipulator650. The implant manipulator 650 may have a first arm 670 and a secondarm 672 that are joined at a spine 674 to define a V-shapedcross-sectional shape, as described in connection with FIG. 5A. Theimplant manipulator 650 may have a selectively bendable portion 680having the cross-sectional shape shown in FIG. 6C. In its unalteredstate, the cross-sectional shape may have an angle 690 between the firstarm 670 and the second arm 672. As shown in FIG. 6C, the angle 690 maybe an acute angle, i.e., an angle less than 90°. The angle 690 may fallwithin the range of 30° to 90°. More particularly, the angle 690 mayfall within the range of 40° to 80°. Yet more particularly, the angle640 may fall within the range of 50° to 70°. Still more particularly,the angle 640 may be 60°.

The implant manipulator 500 generally has high flexural rigidity forbending along the lateral direction 104 or along the transversedirection 106. The larger angle 640 of the implant manipulator 600provides greater flexural rigidity for bending along the lateraldirection 104, but less flexural rigidity for bending along thetransverse direction 106. Conversely, the smaller angle 690 of theimplant manipulator 650 provides greater flexural rigidity for bendingalong the transverse direction 106, but less flexural rigidity forbending along the lateral direction 104. Thus, the angulation of arms ina V-shaped cross-section may be tailored meet the desired bendingcharacteristics of the instrument. Additionally, the length of the armsmay be altered to further alter the stiffness and profile of theinstrument.

Referring to FIG. 7A, a top elevation view illustrates the distal end312 of the implant manipulator 300 of FIGS. 3A-3C or the needle 400 ofFIGS. 4A-4C in greater detail. The implant interface 360 may take theform of a suture capture feature 360 designed to retain suture 710 inresponse to relative motion by which the suture comes toward the distalend 312, as indicated by the arrow 712.

As in FIGS. 3A-3C and 4A-4D, the suture capture feature 360 may have afirst member 350 and a second member 352, each of which has a tip 354.Each of the tips 354 may be sharp to enable the first member 350 and thesecond member 352 to puncture tissue with relative ease and littletrauma. Thus, each of the tips 354 may be acutely-angled. The suturecapture feature 360 also has a capture hole 730 shaped and sized toreceive the suture, and a channel 732 that extends between the firstmember 350 and the second member 352 to provide access to the capturehole 730.

As shown, the capture hole 730 may have a proximal section 740, a distalsection 742, and an intermediate section 744 between the proximalsection 740 and the distal section 742. The distal section 742 may havea generally semicircular shape, broken by the channel 732, that widenstoward the intermediate section 744. The diameter of the semicircularshape may be sized larger than the uncompressed diameter of the suture710 the suture capture feature 360 is designed to retain. According toone embodiment, the suture capture feature 360 is made to capture a#2suture 710 with an uncompressed outer diameter of about 0.40 mm. Thesemicircular shape of the distal section 742 may be sized to receive thesuture 710 without compression so that the suture 710, when residing inthe distal section 742, may be drawn through the distal section 742along the transverse direction 106. According to one example, thediameter of the semicircular shape of the distal section 742 is about0.76 mm. In alternative embodiments, this diameter ranges from 0.50 mmto 1.00 mm, or more particularly from 0.60 mm to 0.90 mm, or yet moreparticularly from 0.70 mm to 0.80 mm.

The proximal section 740 may also have a generally semicircular shapethat widens toward the intermediate section 744. The diameter of thesemicircular shape of the proximal section 740 may be smaller than theuncompressed diameter of the suture 710 so that the suture 710 can bewedged within the proximal section 740 by urging the suture 710 againstthe proximal section 740 in the direction shown by the arrow 712. Thus,the suture 710 may be firmly retained to restrict further relativemotion between the suture 710 and the distal end 312 in any direction,and particularly, in the transverse direction 106. The extended lengthof the capture hole 730 may also increase the ability of the first arm350 and the second arm 352 to flex outward relative to each other towiden the channel 732, thereby permitting passage of the suture 710through the channel 732. According to one example, the diameter of thesemicircular shape of the proximal section 740 is about 0.25 mm. Inalternative embodiments, this diameter ranges from 0.05 mm to 0.45 mm,or more particularly from 0.15 mm to 0.35 mm, or yet more particularlyfrom 0.20 mm to 0.30 mm.

The intermediate section 744 may have straight walls that define a taperangle 746 leading from the distal section 742 to the proximal section740. The taper angle 746 may control how much force is needed to capturethe suture 710 in the proximal section 740, and also controls theoverall length of the capture hole 730. A more gentle taper angle 746may enable capture with less force. According to one embodiment, thetaper angle 746 may be about 30°. According to alternative embodiments,the taper angle 746 ranges from 10° to 50°, or more particularly, from20° to 40°, or yet more particularly, from 25° to 35°.

In addition to controlling suture retention characteristics, the shapeof the capture hole 730 may also control deflection of the first member350 and the second member 352. The first member 350 and the secondmember 352 may deflect apart to enable the suture 710 to pass from alocation distal to the distal end 312 into the capture hole 730. In thealternative, the distal end 312 may be rigid enough that there is nosignificant outboard flexure of the first member 350 and the secondmember 352. Thus, the suture 710 may simply deflect sufficiently to passthrough the channel 732 without significant flexure of the suturecapture feature 360.

In alternative embodiments, a capture hole may take on a number ofdifferent shapes. For example, including round, oval, rectangular,square, triangular, or any combination of these or other similar shapesmay be used. The shape of the suture capture hole may be adapted to thedesired retention characteristics of the suture capture hole, the typeof suture to be used, the surrounding material available, and otherfactors.

The channel 732 may have a proximal section 750, a distal section 752,and an intermediate section 754. The suture 710 may enter through thedistal section 752, pass through the intermediate section 754, and thenpass through the proximal section 750 to enter the capture hole 730.Thus, the distal section 752 may advantageously be large enough toreceive the suture 710 without precise alignment of the suture 710 withthe axis of the distal end 312. This would allow for some variance orerror in the trajectory that the distal end 312 takes towards the suture710, post, and/or other features present on an associated instrumentthat facilitate spreading of the first member 350 and the second member352, or that help urge motion of the suture 710 through the channel 732.The space between the tips 354 may advantageously not be so large as toadversely affect the ability of the needle to easily penetrate throughtissue, or to cause unnecessary trauma to the tissue.

According to one example, the tips 354 of the first member 350 and thesecond member 352, when in their natural or undeflected state, may beabout 0.76 mm apart when used with a #2 sized suture. This distance maybe about twice the diameter of the suture used; this ratio may be usedto properly dimension a distal end like the distal end 312 for a widerange of suture sizes. This distance may be the same as the width of thecapture hole 730 in the lateral direction 104. In alternativeembodiments, this displacement ranges from 0.50 mm to 1.00 mm, or moreparticularly from 0.60 mm to 0.90 mm, or yet more particularly from 0.70mm to 0.80 mm.

The distal section 752 may taper toward the intermediate section 754with a taper angle 756 that is large enough to guide the suture 710 froma variety of possible locations between the tips 354 to the intermediatesection 754. According to one embodiment, the taper angle 756 may beabout 20°. According to alternative embodiments, the taper angle 756ranges from 5° to 35°, or more particularly, from 10° to 30°, or yetmore particularly, from 15° to 25°.

The intermediate section 754 may also have a taper angle 758 which maybe smaller (i.e., shallower) than the taper angle 756. The taper angle758 may be selected such that, as the suture 710 passes through theintermediate section 754, the suture 710 pushes the walls of theintermediate section 754 apart to induce flexure in the distal end 312to spread the first member 350 and the second member 352 apart. However,the suture 710 may lack the rigidity to flex the first member 350 andthe second member 352 apart. Thus, according to one embodiment of theinvention, the distal end 312 may be flexed by the introduction of apost into the channel 732. This will be shown in connection with FIGS.22-28. The taper angle 758 additionally or alternatively may also beselected such that the suture 710 is compressed to the desired extentprior to entry into the proximal section 750. In the alternative, asmentioned previously, the first member 350 and the second member 352 maybe designed such that they do not flex apart. In such an embodiment, apost may not need to be used.

The taper angle 758 may control how much force is needed to get thesuture 710 and/or the post to pass through the intermediate section 754and into the proximal section 750. A small or shallow taper angle 758may facilitate entry of the suture 710 and/or post into the proximalsection 750 but may require additional motion of the distal end 312along the longitudinal direction 102 to position the suture 710 and/orpost within the proximal section 750. Conversely, a steeper or largertaper angle 758 may increase the force, but reduce the displacement,required to position the suture 710 and/or post within the proximalsection 750.

According to one example, the taper angle 758 may be about 10°.According to alternative embodiments, the taper angle 758 ranges from2.5° to 17.5°, or more particularly, from 5° to 15°, or yet moreparticularly, from 7.5° to 12.5°.

The proximal section 750 may have walls that are substantially parallelto each other. The walls may be spaced apart such that the suture 710must compress to pass through the proximal section 750, whether or not apost is used to cause flexure of the distal end 312. The walls mayfurther be spaced apart such that, even with the first member 350 andthe second member 352 flexed apart, the proximal section 750 remains toosmall to permit the suture 710 to pass through without compression ofthe suture 710. This may have the advantage of enabling the suture 710to be captured against the corners defined by the intersection of thedistal section 742 of the capture hole 730 with the proximal section 750of the channel 732. However, in alternative embodiments, when flexedapart, the walls of the proximal section may be sufficiently spacedapart to permit the suture 710 to pass relatively freely through theproximal section, i.e., without significant compression of the suture710. In other alternative embodiments, the walls of the proximal sectionmay be sufficiently spaced apart to permit the suture 710 to passrelatively freely therethrough without flexure of the suture capturefeature.

More specifically, once the suture 710 is positioned within the capturehole 730, the distal end 312 may be drawn proximally such that thesuture 710 is pinched between the corners and/or compressed against thecorners defined by the intersection of the distal section 742 of thecapture hole 730 with the proximal section 750 of the channel 732. Thispinching motion may restrict further motion of the suture 710 until itis pulled proximally toward the center of the capture hole 730. Inparticular, motion of the suture 710 in the transverse direction 106 maybe restricted or prevented by this pinching motion. Thus, the suture 710can be drawn through a hole in tissue or in an implant within the bodyas the distal end 312 is drawn proximally.

According to one example, where the suture 710 has an uncompresseddiameter of 0.40 mm, the walls of the proximal section 750 may be spacedapart 0.25 mm. The walls of the proximal section 750 may be spaced apartby a distance equal to the diameter of the semicircular shape of theproximal section 740 of the capture hole 730. In alternativeembodiments, the wall spacing ranges from 0.05 mm to 0.45 mm, or moreparticularly from 0.15 mm to 0.35 mm, or yet more particularly from 0.20mm to 0.30 mm.

Various other dimensions of the exemplary embodiment of FIG. 7A will beprovided, as follows. The longitudinal lengths of the proximal section740, the distal section 742, and the intermediate section 744 of thecapture hole 730 may be about 0.125 mm, about 0.38 mm, and about 0.94mm, respectively. The longitudinal lengths of the proximal section 750,the distal section 752, and the intermediate section 754 of the channel732 may be about 0.43 mm, about 1.27 mm, and about 0.35 mm,respectively. The distal end 312 may be 0.223 mm wide proximally of thefirst member 350 and the second member 352. These dimensions may beparticularly applicable to the capture of the #2suture referenced above;accordingly, all of the linear dimensions set forth herein may need tobe increased or decreased if the suture to be captured is larger orsmaller, respectively, than a #2suture.

In operation, the distal end 312 may first be aligned with the suture710 and/or post, at least so that the majority of the suture 710 and/orpost is positioned inboard of the tips 354 of the first member 350 andthe second member 352. The distal end 312 may then be advanced towardthe suture 710 and/or post so that the suture 710 and/or post enters thedistal section 752 of the channel 732. The distal end 312 may be furtheradvanced so that the suture 710 and/or post passes into the intermediatesection 754.

The distal end 312 may be further urged distally so that the suture 710and/or post spreads the walls of the intermediate section 754 apart tocause the first member 350 and the second member 352 to move apartand/or compress the suture 710. The distal end 312 may be further urgeddistally so that the suture 710 and/or post enters the proximal section750 of the channel 732. Further urging of the distal end 312 distallymay cause the suture 710 and/or post to advance through the proximalsection 750 of the channel 732, thereby driving the first member 350 andthe second member 352 further apart and/or further compress the suture710. Then, the suture 710 and/or post may enter the capture hole 730.

With the suture 710 in the capture hole 730, the distal end 312 may beurged proximally to pinch the suture 710 between the corners defined bythe intersection of the distal section 742 of the capture hole 730 withthe proximal section 750 of the channel 732. The distal end 312 may befurther urged proximally until the distal end 312 is outside the body,where the suture 710 may be shifted back toward the center of thecapture hole 730 and then moved along the transverse direction 106 toexit the capture hole 730.

Alternatively, with the suture 710 in the capture hole 730, the distalend 312 may be urged distally to pinch the suture 710 between thetapering walls of the intermediate section 744 and/or between theopposing sides of the proximal section 740 of the capture hole 730. Thedistal end 312 may then be urged proximally as set forth above, and thesuture 710 may be moved toward the center of the capture hole 730 topermit the suture 710 to move transversely out of the capture hole 730.

In the alternative to the foregoing capture method, suture capture maybe carried out without significant flexure of the distal end 312. Thismay be accomplished without the use of a post. In such an alternativemethod, the steps are similar to those set forth above, but without theassociated flexure of the first member 350 and the second member 352. Inplace of such flexure, the suture 710 may compress to move through thechannel 732. Alternatively, a pusher (not shown) can be used to push thesuture 710 material through channel 732 and into the capture hole 730.Lastly, two ends of the suture 710 may be grasped to secure the suture710 as it is either pulled into the suture capture hole 10, or thedistal end 312 is advanced until the suture 710 resides in the capturehole 730.

Referring to FIG. 7B, a top elevation view illustrates the distal end762 of an implant manipulator (not shown) according to anotheralternative embodiment. The implant manipulator may have a proximal end310 and an intermediate portion 314 like those of the needle 300 ofFIGS. 3A-3C or the needle 400 of FIGS. 4A-4C. The distal end 762 mayhave an implant interface 764 that may take the form of a suture capturefeature 764 designed to retain suture 710 in response to relative motionby which the suture comes toward the distal end 312, as indicated by thearrow 712. The distal end 762 may also have a first member 770 and asecond member 772, each of which has a tip 774 with an acute angleselected to facilitate puncturing of tissue.

The suture capture feature 764 is somewhat similar to the suture capturefeature 360. The suture capture feature 764 may have a capture hole 780and a channel 782 extending between the first member 770 and the secondmember 772 to provide access to the capture hole 780 from distally ofthe distal end 762. The suture capture feature 764 may generallyfunction similarly to the suture capture feature 360 shown in FIG. 7A.Thus, in response to motion of the suture 710 and/or a post along thedirection shown by the arrow 712, the first member 770 and the secondmember 772 may spread apart and/or the suture 710 may be compressed asit travels through the channel 782.

The capture hole 780 and the channel 782 are different from those of thesuture capture feature 360 of FIG. 7A. More specifically, the capturehole 780 may simply be circular in shape, except where it joins thechannel 782. The capture hole 780 may be sized somewhat larger than theuncompressed diameter of the suture 710. For a #2suture, the capturehole 780 may be 0.76 mm in diameter. The channel 782 may have a proximalsection 790, a distal section 792, a distal intermediate section 794,and a proximal intermediate section 796. The proximal section 790, thedistal section 792, and the proximal intermediate section 796 may besubstantially the same as the proximal section 750, the distal section752, and the intermediate section 754, respectively, of the suturecapture feature 360.

The distal intermediate section 794 may be between the distal section792 and the proximal intermediate section 796. The distal intermediatesection 794 may have substantially straight, parallel walls like thoseof the proximal section 790, but with a larger width. The walls of thedistal intermediate section 794 may be 0.30 mm apart.

The distal intermediate section 794 may serve to lengthen the channel782. This may serve to facilitate flexure of the first member 770 andthe second member 772, as a longer moment arm is acting on them duringpassage of the suture 710 and/or the post through the channel 782. Thedistal intermediate section 794 may also divide the tactile response ofthe implant manipulator into more distinct events so that a surgeon caneasily tell by the feel of the instrument where the suture 710 is. Forexample, the surgeon, if operating the implant manipulator manually, mayfeel some resistance as the suture 710 enters the distal intermediatesection 794 from the distal section 792. The surgeon may feel a distinctresistance again when the suture 710 passes from the distal intermediatesection 794, through which it passes relatively freely, to the proximalintermediate section 796.

Referring to FIGS. 8 and 9, perspective views illustrate how the needle400 of FIGS. 4A-4C may bend. As mentioned previously, the selectivelybendable portion 430 may be reconfigurable to enable significant bendingalong the lateral direction 104 or the transverse direction 106. In FIG.8, the needle 400 is shown bent in a downward direction, along thetransverse direction 106. The proximal end 310 and the distal end 312may still have the original V-shaped cross-sectional shape; the presenceof the spine 424 at the proximal end 310 and the distal end 312 mayrestrict the ability of the cross-sectional shape at the proximal end310 and the distal end 312 to change. However, the slot 440 may allowthe first arm 320 and the second arm 322 to rotate relative to eachother about the longitudinal direction 102 so that the first arm 320 andthe second arm 322 become substantially coplanar, as shown in FIG. 2C.This enables the selectively bendable portion 430 to bend along thetransverse direction 106 so that the distal end 312 can bend upward ordownward relative to the proximal end 310.

FIG. 8 shows the selectively bendable portion 430 flexed to orient thedistal end 312 downward relative to the proximal end 310. Similarly,with the first arm 320 and the second arm 322 in the generally coplanarconfiguration, the selectively bendable portion 430 may flex to orientthe distal end 312 upward relative to the proximal end 310.

A transitional region 810 may exist between the proximal end 310 and theselectively bendable portion 430, wherein the cross-sectional shapetransitions between the V-shaped cross-sectional shape of the proximalend 310 to the generally coplanar cross-sectional shape of theselectively bendable portion 430. The proximal end 310 may thus remainrelatively rigid relative to bending along the lateral direction 104 andthe transverse direction 106. This may facilitate retention of theproximal end 310 in a user's hand (not shown), in an actuator (notshown), or in another instrument (not shown).

A transitional region 812 may similarly exist between the distal end 312and the selectively bendable portion 430, wherein the cross-sectionalshape transitions between the V-shaped cross-sectional shape of thedistal end 312 to the generally coplanar cross-sectional shape of theselectively bendable portion 430. The distal end 312 may thus remainrelatively rigid relative to bending along the lateral direction 104 andthe transverse direction 106. This may facilitate retention of animplant such as the suture 710 with the distal end 312, and may alsofacilitate puncturing of tissue with the distal end 312. If the distalend 312 were to be easily bendable in the lateral direction 104 or thetransverse direction 106, axial force pressing the tips 354 into tissuecould lead the tips 354 to skive or otherwise deflect from the tissue tobe penetrated as the distal end 312 buckles or bends. Thus, keeping thedistal end 312 relatively rigid may provide distinct advantages for theinvention.

FIG. 9 shows the selectively bendable portion 430 flexed to orient thedistal end 312 to the right relative to the proximal end 310. Similarly,with the first arm 320 and the second arm 322 in the generally parallelconfiguration like that of FIG. 2D, the selectively bendable portion 430may flex to orient the distal end 312 to the left relative to theproximal end 310.

A transitional region 912 may exist between the distal end 312 and theselectively bendable portion 430, wherein the cross-sectional shapetransitions between the V-shaped cross-sectional shape of the distal end312 to the generally parallel cross-sectional shape of the selectivelybendable portion 430. The distal end 312 may thus remain relativelyrigid relative to bending along the lateral direction 104 and thetransverse direction 106. As mentioned previously, the relative rigidityof the distal end 312 may facilitate implant retention and/or tissuepenetration. A similar transitional region may exist between theproximal end 310 and the selectively bendable portion 430.

Referring to FIGS. 10A-11B, there are a number of mechanisms by which asuture, such as the suture 710, may be retained by an implant interfacesuch as the suture capture feature 764 of FIG. 7B. As mentionedpreviously, one such mechanism is deflection of the distal end 762 thatspreads the first member 770 and the second member 772 apart. Suchdeflection may be carried out by a post or pusher (not shown), or by thesuture 710 itself. Different modes of flexure are possible, as will beshown and described in connection with FIGS. 10B and 11B.

FIGS. 10A and 11A provide a top elevation view and an end view,respectively, of the distal end 762 of FIG. 7B, in the undeflectedstate. The channel 782 thus has the shape shown in FIG. 7B, and thefirst member 770 and the second member 772 extend generally parallel toeach other. The first member 770 and the second member 772 may begenerally orthogonal to each other, as best seen in FIG. 11A. Moreprecisely, the first member 770 generally resides in a first plane 1110,and the second member 772 generally resides in a second plane 1112 thatis generally orthogonal to the first plane 1110.

In FIG. 10B, the first member 770 and the second member 772 have beenspread apart along the lateral direction 104 to enable the suture 710 topass through the channel 782 and into the capture hole 780. This motioninvolves out-of-plane motion of each of the first member 770 and thesecond member 772. An item that moves out-of-plane moves in a mannerthat removes it from the plane in which it was prior to the motion.Thus, a thin, flat object that rotates about an axis perpendicular toits large face moves in-plane. Likewise, such an object that moves in adirection parallel to its large face moves in-plane. However, if such anobject rotates about an axis that is non-perpendicular to its largeface, or moves along a direction nonparallel to its large face, suchmotion is out-of-plane.

The first member 770 and the second member 772 may each moveout-of-plane to reach the configuration shown in FIG. 10B because eachof the first and second members 770, 772 moves out of the plane in whichit naturally resides. Thus, the first member 770 moves out of the firstplane 1110 and the second member 772 moves out of the second plane 1112.

In FIG. 11B, the channel 782 is opened through a different mechanism.More specifically, the first arm 320 and the second arm 322 may becompressed toward each other. As a result, the walls of the channel 782may generally flex apart to widen the channel 782. This may beaccomplished through the use of an instrument (not shown) that has awindow or side walls that reduce in width, such that when the distal end312 is advanced through the instrument, the first arm 320 and the secondarm 322 are compressed against the side walls to open the channel 782.Again, out-of-plane flexure of the first member 770 and the secondmember 772 has occurred to open the channel 782 sufficiently toaccommodate passage of the suture 710.

In an alternative embodiment (not shown), the walls of the channel 782may be angled differently than shown in FIG. 11A to enhance this effect.For example, in place of the configuration of FIG. 11A, the walls of thechannel 782 may be angled toward each other so that the channel 782 isnarrower at the top than it is at the bottom. Thus, when the first arm320 and the second arm 322 are compressed toward each other, the wallsof the channel 782 may be brought into a more nearly parallelconfiguration, thereby increasing the width of the narrowest portion ofthe channel 782.

The various implant manipulators shown and described in FIGS. 1-11B maybe used with a wide variety of instruments. In some embodiments, anactuator may be used to control advancement of the implant manipulatorinto and out of the tissue. Such actuators may be manually operated ordrive through the use of motors and/or control systems. FIGS. 12-33illustrate a number of various instruments that may be used with rigidor flexible implant manipulators. Several of these instruments aredesigned for use with flexible implant manipulators that pass suturethrough tissue; those of skill in the art will readily comprehend howtheir use and configuration may be adapted to rigid implant manipulatorsand/or implant manipulators designed for use with other implants such asbone anchors, joint replacements, grafts, and the like.

Referring to FIG. 12, a side elevation view illustrates an actuator,which may take the form of an instrument 1200 that may be used to passthe needle 400 into a desired location within tissues such that thedistal end 312 is able to capture, retain, and reposition suturetherein. The instrument 1200 may thus be called a suture passer. Theinstrument 1200 may have a proximal end 1210, a distal end 1212, and anintermediate portion 1214. The instrument may pass the distal end 312between a pair of tissue grasping jaws including an upper jaw 1220 and alower jaw 1222 at the distal end 1212 of the instrument 1200.

The upper jaw 1220 may pivot around a pin in the lower jaw 1222 androtate toward and away from the lower jaw 1222. The distal end 312 ofthe needle 400 may pass upward from the lower jaw 1222 toward the upperjaw 1220. The upper jaw 1220 may temporarily capture a strand of suturematerial that is ultimately retrieved by the suture capture feature 360of the needle 400 and pulled back down toward the lower jaw 1222. Astructure like that of FIG. 27 may optionally be used to temporarilyretain the suture.

The proximal end 1210 of the instrument 1200 may include a chassis 1228that generally contains the mechanical workings (not shown) of theinstrument 1200, a handle 1230, a first user control, which may take theform of a first trigger 1232, and a second user control, which may takethe form of a second trigger 1234. According to one example, the secondtrigger 1234 may be used to control actuation of the needle 400 throughthe instrument 1200, and the first trigger 1232 may control actuation ofthe upper jaw 1220 toward the lower jaw 1222. Thus, a surgeon mayindependently control grasping of tissue and puncture and sutureretrieval through the tissue. Those of skill in the art will recognizethat many other types of user controls may be used in the alternative tothe first trigger 1232 and the second trigger 1234, including sliders,push buttons, and the like. Additionally, in alternative embodiments,one or more than two user controls may be provided and may performfunctions different from those recited above.

The intermediate portion 1214 may have a shaft 1240 that is of adequatelength such that the handle 1230 and the chassis 1228 may remain outsidethe body while the distal end 1212 is inserted through a working portalor cannula to reach a joint space, a wound, or another anatomical regionthat requires suturing.

Referring to FIGS. 13A-14C, the lower jaw 1222 of the instrument 1200 isshown in greater detail. FIGS. 13A and 13B, side elevation and topelevation views, respectively, illustrate the lower jaw 1222 of theinstrument 1200 in greater detail. FIGS. 14A-14C illustrate sectionviews of various portions of the lower jaw 1222. The lower jaw 1222 mayhave a bore 1250 shaped to cause the needle 400 to bend as it movesthrough the lower jaw 1222 in a manner similar to that of FIG. 8.

In order to accomplish the varying cross-sectional shapes of the needle400, the lower jaw 1222 may include three distinct sections including afirst section 1252, a second section 1254, and a third section 1256 asshown in FIG. 13A. The first section 1252 may accommodate the needle 400with its substantially undeflected V-shaped cross-sectional shape, asshown in FIG. 2B. The cross-sectional shape of the first section 1252may be relatively rectangular as shown in FIG. 14A.

The second section 1254 may accommodate the needle 400 with itssubstantially flat, coplanar cross-sectional shape, as shown in FIG. 2C.The cross-sectional shape of the second section 1254 may thus be arelatively thin, wide rectangular shape, as shown in FIG. 14B, bycomparison with the first section 1252. In order to assist this shapechange, a first transitional region 1258 may be present between thefirst section 1252 and the second section 1254. In this firsttransitional region 1258, the cross-sectional shape of the bore 1250gradually alters between the shape of the first section 1252 and theshape of the second section 1254.

The third section 1256 may then cause the needle 400 to revert back tothe more rigid V-shaped configuration as it exits an aperture 1260 ofthe lower jaw 1222 as shown in FIG. 13B. In this third section 1256, thecross-sectional shape may be substantially V-shaped as shown in FIG.14C. A second transitional region 1262 may also exist between the secondsection 1254 and the third section 1256 to gradually force thecross-sectional shape of the needle 400 to change as it passes from thesecond section 1254 to the third section 1256. Thus, the needle 400 maybend to extend upward, toward the upper jaw 1220, and yet retainsufficient stiffness at the aperture 1260 to enable it to effectivelypierce tissue. “Piercing” tissue relates to pushing a sharp feature intothe tissue to form an opening in the tissue, as opposed to simply movinga feature into an existing hole in the tissue.

Referring to FIG. 15, a side elevation view illustrates an instrument1500 according to one alternative embodiment. The instrument 1500 may bea suture passer with a proximal end 1210 and an intermediate portion1214 like those of FIG. 12. However, the instrument 1500 may have adistal end 1512 with an upper jaw 1520 and a lower jaw 1522 that areconfigured differently from those of FIG. 12.

The instrument 1500 may pass an implant manipulator, such as the needle400 of FIGS. 4A-4C, from the upper jaw 1520 to the lower jaw 1522. Thelower jaw 1522 may temporarily capture a strand of suture material thatis ultimately retrieved by the suture capture feature 360 of the needle400 and pulled back up toward the upper jaw 1520. Thus, the upper jaw1520 may have a bore like the bore 1250 of the instrument 1200 of FIGS.12-14C.

As mentioned previously, the distal end 312 of the needle 400 may havethe spine 424 intact, and may thus be resistant to flexure into the flatcross-sectional shape shown in FIG. 2C to permit bending of the distalend 312. There are a number of alterations to the upper jaw 1520 and thelower jaw 1522 that can be made that would allow for the distal end 312of the needle 400 to remain in the V-shaped configuration while theneedle 400 only bends in the regions where the slot 440 exists (e.g., inthe selectively bendable portion 430).

According to one example, an instrument like the instrument 1500 mayhave an upper jaw or a lower jaw with a movable distal tip thattranslates, slides, pivots, or rotates to move the distal tip of theneedle, without deformation, from a first position substantiallyparallel to the long axis of the instrument to a second positionsubstantially perpendicular to the long axis of the instrument. One suchexample will be shown and described in connection with FIGS. 16A-18B.

Referring to FIGS. 16A-18B, a variety of views illustrate a distal end1612 of an instrument (not shown) according to another embodiment of theinvention. The distal end 1612 may have an upper jaw 1622 (or in otheralternative embodiments, a lower jaw) with a main body 1650 and asliding tip 1652. The distal end 1612 may facilitate re-orienting of thedistal end 312 of the needle 400 in a manner that does not requiresignificant bending of the distal end 312.

The sliding tip 1652 may have a first position and a second position. Inthe first position, the sliding tip 1652 may be displaced from the mainbody 1650 along the axis of the distal end 1612 so that the needle 400remains in a substantially straight configuration, proximal to distal,that is parallel to the upper jaw 1622. This first position isillustrated in FIG. 17. In a second position shown in FIGS. 18A-18B, thesliding tip 1652 may be retracted proximally such that it is positionedimmediately adjacent to the main body 1650. The distal end 312 of theneedle 400 is shown exiting the upper jaw 1622 in a directionsubstantially perpendicular to the upper jaw 1622.

As best seen in FIGS. 16A and 16B, the sliding tip 1652 may have aninterior contour 1660 defining a curved wall 1662, a V-shaped wall 1664at the exit point of the upper jaw 1622, and a transitional region 1666where the interior contour 1660 gradually transforms from the shape ofthe curved wall 1662 to that of the V-shaped wall 1664.

As the distal end 312 of the needle 400 is advanced through the upperjaw 1622, or the upper jaw 1622 is retracted, the distal end 312 of theneedle 400 may initially begin to deflect downward as it contacts thecurved wall 1662 of the upper jaw 1622. The flexure may occur along theregion of the needle 400 where the slot 440 exists, e.g., theselectively bendable portion 430. The first arm 320 and the second arm322 of the needle 400 may undergo a shape change from the V-shapedconfiguration (as in FIG. 2B) to a relatively flat configuration (as inFIG. 2C) such that the needle 400 can bend. As the needle 400 is furtheradvanced, the distal end 312 may exit the upper jaw 1622 at the V-shapedwall 1664.

As the selectively bendable portion 430 of the needle 400 reaches theV-shaped wall 1664, the first arm 320 and the second arm 322 may beforced back to a V-shaped configuration (as in FIG. 2B) as they slidealong the interior contour 1660. The main body 1650 of the upper jaw1622 may have an extending feature 1670 with a peaked surface 1672 thatrepresents the interior portion of the V-shape, the exterior portion ofwhich is provided by the V-shaped wall 1664, as shown in FIG. 18B. TheV-shaped wall 1664 and the peaked surface 1672 may thus cooperate toforce the first arm 320 and the second arm 322 of the needle 400 to exitthe upper jaw 1622 in the generally rigid V-shaped configuration. Twoextension arms 1680 may be in contact with the main body 1650 of theupper jaw 1622 to slidably couple the sliding tip 1652 to the main body1650. The extension arms 1680 may be connected to an actuation rod (notshown) that connects to one of the user controls (not shown) of theinstrument, allowing for the user to control the extension and/orretraction of the sliding tip 1652 relative to the main body 1650.

In the alternative to positioning such a mechanism on the upper jaw1622, a corresponding lower jaw 1620 (not shown) may be modified to havea main body 1650 and a tip 1652 like those shown in FIGS. 16A-18B.Alternatively, the distal end 312 of the needle 400 may be capturedinside a pivoting tip (not shown) of one of the jaws. As the pivotingtip pivots from a first position to a second position, the selectivelybendable portion 430 of the needle 400 may flex and pivot around thecurve while the distal end 312 remains in the V-shaped configuration.

The embodiments described above describe an instrument for which theneedle may be inserted from the proximal end of the instrument andtravels towards the distal end. However, in alternative embodiments, theneedle may be inserted into the distal end of the instrument and movedproximally to seat in the proximal end.

Referring to FIGS. 19-21B, a variety of views illustrate a distal end1912 of an actuator (not shown) according to another embodiment of theinvention. As shown, the actuator may have an intermediate portion 1914in addition to the distal end 1912. The distal end 1912 may have anupper jaw 1920 and a lower jaw 1922 that includes a main body 1950 and acartridge 1952. The cartridge 1952 may be slidably inserted onto the endof the main body 1950. A needle like the needle 400 of FIGS. 4A-4C maybe pre-loaded in the cartridge 1952 to provide an assembly 1954 that canbe inserted into the end of the main body 1950 of the lower jaw 1922.

FIG. 21A illustrates one manner in which the assembly 1954 may beinserted into engagement with the main body 1950. As shown, the proximalend 310 of the needle 400 may be inserted into the corresponding opening(not shown) in the main body 1950 of the lower jaw 1922. The assembly1954 may need to be rotated to cause the needle 400 to flex such thatthe assembly 1954 can be fully inserted into main body 1950 as shown inFIG. 21B.

In general, the instrument of FIGS. 19-21B may provide the benefit ofavoiding the needle having to pass through the distal end 312 through anonlinear actuation pathway. Since the distal end 312 is positionedbeyond the end of the bore that extends through the intermediate portion1914 and through the lower jaw 1922, it need not follow a curvedpathway. Rather, the intermediate portion 414, or more specifically, theselectively bendable portion 430, may bend to orient the distal end 312generally perpendicular to the length of the instrument, as shown inFIG. 21B.

In other embodiments of the invention, an implant manipulator need notbend around a curve, but may instead remain in a rigid configuration asit translates along a single plane. As mentioned previously, the implantmanipulator 100 and the implant manipulator 300 may both besubstantially rigid. Such implant manipulators may be used in a widevariety of instruments.

Referring to FIGS. 22-28, various views illustrates an instrument 2200according to another embodiment of the invention. The instrument 2200may also be a suture passer, and may use a rigid needle like the needle300 of FIGS. 3A-3C to pass suture through tissue. The instrument 2200may have proximal end 2210, a distal end 2212, and an intermediateportion 2214 between the proximal end 2210 and the distal end 2212. Theproximal end 2210 may be similar to the proximal end 1210 of theinstrument 1200 of FIGS. 12-14C. Thus, the proximal end 2210 may have ahandle 1230, a first user control in the form of a first trigger 1232,and a second user control in the form of a second trigger 1234. Theintermediate portion 2214 may be similar to the intermediate portion1214.

The distal end 2212 of the instrument 2200 may have a cutout section2220 and jaw 2222 that pivots around a shaft or other pivot pointproximate the distal terminus of the cutout section 2220. The cutoutsection 2220 may provide a location for the tissue to be insertedbetween the distal end 312 of the needle 300, which may reside withinthe interior of the intermediate portion 2214 proximally of the cutoutsection 2220, and the jaw 2222.

The second trigger 1234 may be used to rotate the jaw 2222 between afirst position in which the jaw 2222 is oriented generally parallel tothe intermediate portion 2214, as shown in FIG. 23A, and a secondposition in which the jaw 2222 is oriented generally perpendicular tothe intermediate portion 2214, as shown in FIG. 23B. The first trigger1232 may be used to actuate the needle 300 from a first position inwhich the needle 30 is disposed entirely, or nearly entirely, within theintermediate portion 2214, to a second position in which the distal end312 of the needle 300 extends across the cutout section 2220 to the jaw2222. The needle 300 may be coupled at its proximal end 310 to a tab2236 that connects to a needle carriage device (not shown) that pushesand pulls the needle 300 between the two positions as the first trigger1232 is used.

FIG. 23A shows the jaw 2222 in the first position as described above.The jaw 2222 is substantially parallel to the intermediate portion 2214.This first position may be useful to manipulate the distal end 2212 ofthe instrument 2200 into a working cannula or other narrow access portal(not shown) and into the correct anatomical location because, in thefirst position, the profile of the distal end 2212 of the instrument2200 is minimized.

FIG. 23B shows the jaw 2222 in the second position as described above.The jaw 2222 is substantially perpendicular to the intermediate portion2214. This second position may be useful for suture passing steps as thedistal end 312 of the needle 300 may need to pass into the jaw 2222.Further, this rotation of the jaw 2222 may also allow the height of thejaw 2222 along the transverse direction 106 to exceed the height of theintermediate portion 2214. A link 2238 may be connected to the jaw 2222and to the second trigger 1234 so that actuation of the second trigger1234 rotates the jaw 2222 between the first and second positions.

FIG. 26 is an oblique view showing the jaw 2222 in greater detail. Afirst set of pins 2242 may be used to connect the jaw 2222 to the cutoutsection 2220 and provide a pivot point for the rotation of the jaw 2222relative to the remainder of the instrument 2200. Two aligned holes 2244may be used to connect the jaw 2222 to the actuation link 2238. A window2246 may extend through the width of the jaw 2222 to accommodate passageof distal end 312 of the needle 300. The distal end of the window 2246may have a central post 2248 that can be used to support the suture 710and may be used to spread the suture capture feature 360 on the needle300 as previously described. A slot 2250 may be provided to temporarilycapture a section of a suture such as the suture 710. The narrow widthof the slot 2250 may enable the slot 2250 to securely hold the suture710 to temporarily capture it, while remaining able to release thesuture 710 in response to application of a small removal force, such asthat applied to the suture 710 such as when it is being retrieved by theneedle 300. The slot 2250 may optionally have a boss or other positivefeature (not shown) such as a bump, wedge, or bulge that provides asecondary constraint on the suture.

In FIG. 27, a section of suture 710 is shown temporarily constrainedwithin the slot 2250. The suture 710 may lay adjacent to the centralpost 2248. The suture 710 may be pre-loaded into the instrument 2200prior to use. Once the suture 710 has been pre-loaded onto theinstrument 2200, the jaw 2222 may be placed in the first position (FIG.23A). The instrument 2200 may then be inserted into a working cannula orother portal with access to the desired location, i.e., the anatomicalspace at which suturing is to be performed. The jaw 2222 may then beactuated to the second position adjacent to and behind the piece oftissue 2260 to be sutured, as shown in FIG. 24.

FIG. 25 shows the needle 300 after it has been actuated to an extendedposition. The tips 354 of the needle 300 have punctured the tissue 2260and the distal-most portion of the distal end 312 has passed through thetissue 2260 and into the window 2246 of the jaw 2222. As the distal end312 of the needle 300 is being extended into the jaw 2222, the suture710 may translate into the suture capture feature 360. The central post2248 may serve two purposes during this step of the procedure. First,the suture 710 may be prevented from being pushed distally by theadvancing distal end 312 as the central post 2248 serves as a stop thatthe suture 710 cannot be pushed past. Second, the central post 2248 maybe used to urge the first member 350 and the second member 352 of thedistal end 312 to move apart (as shown in FIGS. 10B and/or 11B),allowing the suture 710 to enter the capture hole 730.

The needle 300 may then be retracted towards the proximal end 2210 ofthe instrument 2200 with the suture 710 retained in the capture hole 730so that the suture 710 is drawn back through the tissue 2260 as shown inFIG. 28. The needle 300 may be retracted back into the intermediateportion 2214 such that the suture 710 is compressed between the interiorwall of the intermediate portion 2214 and the needle 300, whichcompression may more securely lock the suture 710 in place. As thedistal end 2212 of the instrument 2200 is then removed from the body,the suture 710 may be retained securely so as to not be dislodged fromthe instrument 2200. Lastly, to remove the suture 710 from theinstrument 2200, the needle 300 may need to be slightly advanced, suchthat one end of the suture 710 can be pulled along the transversedirection 106 (i.e., up or down with reference to FIG. 28) and out ofthe capture hole 730.

The instrument 2200 provides a linear pathway for travel of the needle300; accordingly, use of the generally rigid needle 300 is suitable. Inalternative embodiments, the instrument 2200 may be modified to have anonlinear actuation pathway for needle travel. For example, theintermediate portion 2214 may be curved along a radius of curvature toenable the distal end 2212 to move along an arcuate pathway through thebody. Alternatively, the intermediate portion 2214 may remain straight,but the needle may be guided along a nonlinear actuation pathwayproximate the distal end 2212.

In such embodiments, a flexible needle like the needle 400 of FIGS.4A-4C may be used. According to one alternative embodiment, shown inFIG. 29, the needle 400 may need to travel along a pathway that curvesat the distal end to provide a greater bite depth of tissue. In FIG. 29,an instrument (not shown) may be configured generally similarly to theinstrument 2200 of FIGS. 22-28, except that the instrument of FIG. 29has a distal end 2912 and an intermediate portion 2914 configured tocarry out suturing with a greater bite depth in the tissue 2260. Thus,the distal end 312 of the needle 400 may exit the intermediate portion2914 at an upward angle. The distal end 2912 may have a cutout section2220, a jaw 2922, and a link 2238 that operate in a manner generallysimilar to those of the instrument 2200.

A feature such as a ramp, bump, post, pin or other feature may bepositioned within the interior of the intermediate portion 2914,proximate its distal opening. The distal end 312 of the needle 400 maycontact such a feature, which may then redirect the distal end 312 ofthe needle 400 as it exits the interior of the intermediate portion2914. With this modified exit angle, the height of the jaw 2922 (alongthe transverse direction 106 as shown in FIG. 29) and/or location of thewindow 2246 (not shown in FIG. 29) may need to be altered from those ofthe jaw 2222 of FIGS. 22-28 so that the window 2246 can accommodatepassage of the angled distal end 312.

FIG. 30 is a side elevation, section view illustrating an intermediateportion 3014 of an instrument (not shown) according to anotheralternative embodiment of the invention. The needle 400 may exit theintermediate portion 3014 through a window 3070, which may be on theupper surface of the intermediate portion 3014. This may allow theneedle 400 to exit the intermediate portion 2914 at a more proximallocation, while still keeping the overall profile of the entireinstrument substantially the same so that it still fits through thedesired cannula or other portal to the working location within the body.If desired, one or more various features such as ramps, bumps, posts,pins or the like may be positioned within the interior of theintermediate portion 3014 or outside the intermediate portion 3014 toenable the needle 400 to move along the nonlinear actuation pathwayshown in FIG. 30.

In FIG. 31, a perspective view illustrates an instrument 3100 accordingto another embodiment of the invention. The instrument 3100 may have adistal end 2212 and intermediate portion 2214 like those of theinstrument 2200 of FIGS. 22-28. However, the instrument 3100 may alsohave a proximal end 3110 that is different from the proximal end 2210 ofthe instrument 2200.

The proximal end 3110 of the instrument 3100 may have a handle 3130 witha straight style different from the pistol grip style illustrated inother figures herein. As with previous embodiments, the handle design ofFIG. 31 may be used with a wide variety of user controls including pushbuttons, sliders, levers, triggers, or other similar mechanisms. In FIG.31, the proximal end 3110 has a chassis 3128 that generally contains themechanical workings (not shown) of the instrument 3100. A first usercontrol may take the form of a push button 3132, and a second usercontrol may take the form of a slider 3134. The push button 3132 and theslider 3134 may perform functions similar to the first trigger 1232 andthe second trigger 1234 of FIG. 12. The distal end 2212 of theinstrument 3100 may function in a manner similar to that of theinstrument 2200. The instrument 3100 may simply provide differentergonomics and user controls.

The instruments disclosed herein with upper and lower jaws, such as theinstrument 1200 and the instrument 1500, may have the ability to graspthe piece of tissue to be sutured prior to passing of the needle throughthe tissue. Such grasping may also be provided for instruments withoutsuch jaws like the instruments 2200 and 3000.

Referring to FIG. 32, a distal end 3212 of an instrument (not shown) mayhave a cutout section 3220, a distal wall 3222, proximal jaw 3280 thatmay be used to grasp the tissue prior to suturing. The proximal jaw 3280may extend distally in response to actuation of a user control at theproximal end (not shown) of the instrument until the section of tissueis pinched between the proximal jaw 3280 and the distal wall 3222. Thedistal wall 3222 may be formed as a single piece (i.e., unitarilyformed) with the cutout section 3220, and may thus be a stationaryfeature. This may provide additional rigidity at the distal end 3212,particularly when the tissue is being pinched between the proximal jaw3280 and the distal wall 3222. Alternatively, the distal wall 3222 maybe replaced by a jaw that pivots relative to the cutout section 3220 ina manner similar to that of the jaw 2222 of FIG. 22.

A suture passing instrument according to the invention may also be usedto place a continuous stitch through one or more pieces of tissue. Thismay be accomplished, for example, by housing two opposing needles in thedistal end of the instrument. The needles may then be used to passsuture back and forth through the tissue.

FIGS. 33A-33C illustrate a distal end 3312 of an instrument (not shown)according to another alternative embodiment, showing how a length ofsuture 710 may be passed from a lower jaw 3322 to an upper jaw 3320.FIG. 33A shows the suture 710 temporarily captured in the distal end 321of a lower needle 400 housed within the lower jaw 3322.

In FIG. 33B, the distal end 312 of the lower needle 400 is extended outof the lower jaw 3322 carrying the suture 710 with it toward the upperjaw 3320. Once the distal end 312 of the lower needle 400 reaches thedistal end 312 of an upper needle 400 housed in the upper jaw 3320, thesuture 710 may be passed from the distal end 312 of the lower needle 400to the distal end 312 of the upper needle 400. Additional features suchas posts, wedges, pushers, or the like (not shown) may be positioned inor on the upper jaw 3320, the lower jaw 3322, and/or on the needles 400themselves to open one or both of the channel 732 of the lower needle400 and the channel 732 of the upper needle 400 to facilitate passage ofthe suture 710 from the capture hole 730 of one needle 400 to thecapture hole 730 of the other needle 400.

In FIG. 33C, the lower needle 400 is retracted back into the lower jaw3322, leaving the suture 710 in the upper needle 400. This process maythen be reversed to pass the suture 710 back down from the upper jaw3320 to the lower jaw 3322. The process may be repeated as many times asnecessary to complete the continuous stitch. Each transfer of suture 710to the opposing needle 400 may entail passage of the suture through thetissue. The distal end 3312 may be moved along the lateral direction 104and/or the longitudinal direction 102 between each transfer so that therepeated passage of suture through the tissue defines stitching in thetissue.

As previously described in connection with FIG. 2, a flexible pushersuch as the pusher 200 may be used to push or advance an implant throughthe body. One manner in which this may be done will be shown anddescribed in connection with FIGS. 34-35B.

Referring to FIG. 34, a perspective view illustrates the pusher 200 isshown with a downward bend like that illustrated in FIG. 8 in connectionwith the needle 400. The proximal end 210 and the distal end 212 of thepusher 200 may retain the V-shaped cross-sectional shape shown in FIG.2B, while the slot 240 may allow the first arm 220 and the second arm222 of the pusher 200 to rotate into a substantially coplanarconfiguration as in FIG. 2C. Thus, the selectively bendable portion 230may bend in the transverse direction 106.

The cross-sectional shape at the distal end 212 may be modified in avariety of ways, including the use of V-shaped, round, rectangular,square, oval, star, or hexagonal cross-sectional shapes. The shape atthe distal end 212 may be dependent upon the implant it is designed tomanipulate. In certain embodiments, the distal end 212 may have animplant interface (not shown) with various features that grip,interlock, or otherwise adhere to the implant until release is desired.The implant interface may include an active or passive connectionmechanism including press-fits, collets, or tongue-groove systems,bayonet fittings, or any implant interface known in the art.

FIGS. 35A-35B demonstrate how a pusher 3500 according to anotherembodiment of the invention may be used to insert an implant in the formof a bone anchor 3510 along a curved insertion pathway to reach adesired location. A hollow shaft 3520 may house a pusher 3530, which maybe flexible like the pusher 200 of FIGS. 2A-2D. The distal tip of thepusher 3530 may interface with the bone anchor 3510, which may bedesigned to be pushed into bone.

In FIG. 35A, the pusher 3530 may initially be retracted within thehollow shaft 3520. The bone anchor 3510 may be placed on the surface ofa cortical layer 3540 of the bony implantation site. The pusher 3530 maythen be pushed or extended through the hollow shaft 3520 using anactuator (not shown) on or proximate the hollow shaft 3520 to push thebone anchor 3510 through the cortical layer 3540 and into a cancellouslayer 3550 of bone as shown in FIG. 35B. If desired, one or morefeatures such as clips, clamps, bone screws, or the like may be used totemporarily dock hollow shaft 3520 to the cortical layer 3540 so that acounter force can be applied to the cortical layer 3540 as the boneanchor 3510 is driven through it.

Referring to FIGS. 36A-B, a human knee joint 3600 is shown in anextended position and a flexed position, respectively. The knee joint3600 includes a femur 3602, a tibia 3604, and a patella 3608. A fibula3606 is also shown in its anatomic relationship to the knee joint 3600.The knee joint 3600 also includes, or is proximate to, an iliotibialband 3610, a hamstring tendon 3612, a patellar tendon 3614, a lateralpatellar retinaculum 3616, a quadriceps tendon 3618, a posteriorcruciate ligament 3620, an anterior cruciate ligament 3622, a meniscalligament 3624, and a meniscus 3626. The meniscus 3626 lies betweencomplementary articular surfaces of the femur 3602 and the tibia 3604.

Referring to FIGS. 37-40, another instrument 3700 is shown. Instrument3700 may also be a suture passer, and may be suitable for passing suturethrough tissue anywhere in the body, such as the meniscus 3626 in theknee 3600. The instrument 3700 may have a proximal end 3710, a distalend 3712, and an intermediate portion 3714 between the proximal end 3710and the distal end 3712. The instrument 3700 may use a rigid needle 3716to pass suture through tissue.

The proximal end 3710 may have a straight style handle 3730. The handle3730 may be used with a wide variety of user controls including pushbuttons, sliders, levers, triggers, or other similar controls. Theproximal end 3710 includes a chassis 3728 that generally contains themechanical workings (not shown) of the instrument 3700. A first usercontrol 3732 may take the form of a slider 3732. The slider 3732 maycontrol actuation of a needle 3716 through the instrument 3700. Theinstrument 3700 may be used with a single hand, with the handle 3730held in the palm of the user's hand, and the slider 3732 actuated by thethumb on the same hand.

Referring to FIGS. 38-41A, the distal end 3712 may have a cutout section3720 and a distal wall 3722. The cutout section 3720 may provide alocation for tissue to be inserted between the at least partiallyretracted needle 3716 and the distal wall 3722 (FIG. 38). The distalwall 3722 may be oriented transversely to, or generally perpendicularto, the intermediate portion 3714, in other words forming an angle of45° to 135° with respect to the longitudinal axis of the intermediateportion 3714. FIG. 38 shows a distal wall 3722 which is substantiallyperpendicular to the intermediate portion 3714. The distal wall 3722 maybe formed as a single piece (i.e., unitarily formed) with the cutoutsection 3720, and may thus be a stationary feature. This may provideadditional rigidity at the distal end 3712, particularly when the tissueis being pinched between the needle tip and the distal wall 3722.Alternatively, the distal wall 3722 may be replaced by a jaw that pivotsrelative to the cutout section 3720 in a manner similar to that of thejaw 2222 of FIG. 22. A window 3734 may extend at least partially throughthe distal wall 3722 to accommodate passage of the distal end of theneedle 3716 in line with the intermediate portion 3714. The window 3734may extend longitudinally as shown, and may extend laterally through thedistal wall 3722 in one or two dimensions, i.e., the height and/or widthof the distal wall. The distal end of the window 3734 may have a centralpost 3736 (FIG. 41A) that can be used to support the suture 710 and maybe used to spread the suture capture feature 3760 on the needle 3716 aspreviously described. In some examples, the post 3736 may stand alone,meaning that there is no distinct window framed by distal wall material.A slot 3738 may be provided to temporarily capture a section of a suturesuch as the suture 710. The slot 3738 may extend across a proximal faceof the window 3734, and may be narrower than an uncompressed diameter ofthe suture 710. The narrow width of the slot 3738 may enable the slot3738 to securely hold the suture 710 to temporarily capture it, whileremaining able to release the suture 710 in response to application of asmall removal force, such as that applied to the suture 710 such as whenit is being retrieved by the needle 3716. The slot 3738 may optionallyhave a boss or other positive feature (not shown) such as a bump, wedge,or bulge that provides a secondary constraint on the suture. The window3734, post 3736, and/or slot 3738 may together or separately be referredto as a suture holding feature or a target for the needle 3716. Thedistal wall 3722 may terminate in a distal tip 3718 which may include asharp, blade-like extension 3719 that may be used to cut into or throughvarious tissues such as tendons or ligaments. FIG. 41A shows ablade-like extension 3719 which is divided into two portions by the slot3738, wherein the blade-like extension 3719 is beveled on two sides.This distal tip configuration may be included in any of the distal endsdisclosed herein.

The intermediate portion 3714 may be similar to the intermediateportions 2214, 1214, or other intermediate portions disclosed herein.The intermediate portion 3714 may have a shaft 3740 that is of adequatelength such that the handle 3730 and the chassis 3728 may remain outsidethe body while the distal end 3712 is inserted through a working portalor cannula to reach a joint space, a wound, or another anatomical regionthat requires suturing.

Referring to FIGS. 38-40 and 42A, the needle 3716 may be like the needle300 of FIGS. 3A-3C, or it may have an arcuate or U-shapedcross-sectional shape like the implant manipulator 550 of FIG. 5B. Aneedle 3716 with an arcuate cross-sectional shape is illustrated. Theneedle 3716 includes a suture capture feature 3760 which may be similarto or identical to the suture capture feature 360 of needle 300 shown inFIG. 7A or other suture capture features disclosed herein. The suturecapture feature 3760 may include a first member 3750, a second member3752, a capture hole 3754, and a channel 3756 that extends between thefirst member 3750 and the second member 3752 to provide access to thecapture hole 3754. The first member 3750 and the second member 3752 maybe distally sharpened to easily pierce tissue. The needle 3716 and/orslider 3732 may be spring loaded or spring biased to remain in, and toreturn to, a retracted position except when the slider is urged distallyto actuate, or move, the needle distally toward an extended position ofthe needle. The needle 3716 may reside completely, or at leastpartially, within the interior of the intermediate portion 3714 proximalto the cutout section 3720. The needle 3716 is in a partially retractedposition when the distal tip of the needle is in the proximal half ofthe cutout section 3720, and is in a partially extended position whenthe distal tip of the needle is in the distal half of the cutoutsection.

Referring to FIGS. 38-40, a method of using instrument 3700 may includesome or all of the following steps: loading the suture 710 in the slot3738; manipulating the instrument 3700 to position a tissue portion 3628in the cutout section 3720 (FIG. 38); actuating the needle 3716 topenetrate the tissue portion 3628 (FIG. 39) and push the suture 710 intothe suture capture feature 3760; retracting the needle 3716 to aretracted position, pulling the suture 710 with it (FIG. 40); andremoving the instrument 3700 from the body, pulling the suture 710 withit.

In FIG. 38, a strand of suture 710 is shown temporarily constrainedwithin the slot 3738. The suture 710 may be pre-loaded into the slot3738 of the instrument 3700 prior to use. The distal end 3712 of theinstrument 3700 and the suture 710 may be inserted together into adesired location where suturing is to be performed, such as anintra-articular space in the knee joint 3600 between the distal femur3602 and the meniscus 3626. The distal end 3712 and suture 710 may passthrough a cannula or other portal to access the desired location. Theproximal end 3710 may remain outside the body, or at least outside thesuturing location. Once in the desired location, the distal end 3712 andsuture 710 may be manipulated, moved, positioned, or otherwise orientedso that a tissue portion 3628 is within the cutout section 3720 betweenthe retracted needle 3716 and the distal wall 3722.

In FIG. 39, the needle 3716 is shown in an extended position in whichthe needle 3716 has pierced the tissue 3628, the first member 3750 andthe second member 3752 are received in the window 3734, and the suture710 has entered the channel 3756. This state may be achieved by pushingthe slider 3732 distally, thus advancing the needle 3716 distallythrough the tissue 3628 and at least partially into the window 3734.Pushing the slider 3732 farther distally advance the needle 3716 fartherdistally, and causes the suture 710 to migrate along the channel 3756into the capture hole 3754. When the suture 710 is received in thechannel 3756 and/or capture hole 3754, the needle 3716 is in the fullyextended position.

As discussed previously, once the suture 710 is in the capture hole3754, or captured in an intermediate or proximal section of the channel3756, the needle 3716 can pull the suture 710 out of the slot 3738 andcarry the suture with the needle as the needle is retracted. This stateis illustrated in FIG. 40, which shows that the suture 710 has beenreleased from the slot 3738 and pulled through the tissue 3628 by theretracting needle 3716. Retracting the needle 3716 may involve slidingthe slider 3732 proximally, or simply releasing distal pressure on theslider 3732 to allow the spring bias to return the needle to theretracted position.

The instrument 3700 may then be removed from the suturing location, andmay be removed from the body, pulling the suture 710 with it. The suture710 may be removed from the suture capture feature 3760.

Another portion of the same suture 710, or a different suture, may beloaded into the slot 3738 of the instrument 3700, and the precedingprocess repeated at different locations on the tissue portion 3628 untilthe desired number of stitches are in place. Knots may be tiedperiodically to stabilize the stitches and/or the tissue 3628.

In one example, the preceding process may be executed a first time topass a first free end of the suture 710 through a tissue 3628 toprotrude from a first side of the tissue, the remainder of the suture710 extending from the opposite side of the tissue. The precedingprocess may be executed a second time to pass a second free end of thesuture 710 through a separate location in the tissue 3628 to protrudefrom the first side of the tissue beside the first free end of thesuture 710, the remaining middle portion of the suture 710 forming aloop extending from the opposite side of the tissue. The first andsecond free ends of the suture 710 may be tied in a knot against thefirst side of the tissue 3628 to form a stitch. Multiple independentstitches may be placed in various locations in the tissue by repeatingthe steps in this paragraph for each independent stitch. One of skill inthe art will appreciate the many types of stitches that may be createdby passing suture through tissue with the instrument 3700.

Referring to FIG. 41B, another example of a distal end 4112 is shown foruse with instrument 3700 or 4800, or other similar instruments disclosedherein. The distal end 4112 may have a cutout section 4120 and a distalwall 4122. The cutout section 4120 may provide a location for tissue tobe inserted between an at least partially retracted needle and thedistal wall 4122. The distal wall may be oriented transversely to, orgenerally perpendicular to, the intermediate portion, in other wordsforming an angle of 45° to 135° with respect to the longitudinal axis ofthe intermediate portion. FIG. 41B shows a distal wall 4122 which issubstantially perpendicular to the intermediate portion. The distal wall4122 may be formed as a single piece (i.e., unitarily formed) with thecutout section 4120, and may thus be a stationary feature. This mayprovide additional rigidity at the distal end 4112, particularly whenthe tissue is being pinched between a needle tip and the distal wall4122. Alternatively, the distal wall 4122 may be replaced by a jaw thatpivots relative to the cutout section 4120 in a manner similar to thatof the jaw 2222 of FIG. 22. A window 4134 may extend at least partiallythrough the distal wall 4122 to accommodate passage of the distal end ofthe needle 4116 in line with the intermediate portion. The window 4134may extend longitudinally as shown, and may extend laterally through thedistal wall 4122 in one or two dimensions, i.e., the height and/or widthof the distal wall. The distal end of the window 4134 may have a centralpost 4136 (not shown) that can be used to support the suture 710 and maybe used to spread the suture capture feature 4160 on the needle 4116 aspreviously described. In some examples, the post 4136 may stand alone,meaning that there is no distinct window framed by distal wall material.A slot 4138 may be provided to temporarily capture a section of a suturesuch as the suture 710. The slot 4138 may extend across a proximal faceof the window 4134, and may be narrower than an uncompressed diameter ofthe suture 710. The narrow width of the slot 4138 may enable the slot4138 to securely hold the suture 710 to temporarily capture it, whileremaining able to release the suture 710 in response to application of asmall removal force, such as that applied to the suture 710 such as whenit is being retrieved by the needle 4116. The slot 4138 may optionallyhave a boss or other positive feature (not shown) such as a bump, wedge,or bulge that provides a secondary constraint on the suture. The window4134, post 4136, and/or slot 4138 may together or separately be referredto as a suture holding feature or a target for the needle 4116. Thedistal wall 4122 may terminate in a distal tip 4118 which may include asharp, blade-like extension 4119 that may be used to cut into or throughvarious tissues such as tendons or ligaments. FIG. 41B shows ablade-like extension 4119 which is divided into two portions by the slot4138, wherein the blade-like extension 4119 is beveled on one side, theproximal side facing the cutout section 4120. This distal tipconfiguration may be included in any of the distal ends disclosedherein.

Referring to FIG. 42B, another example of a needle 4216 is shown for usewith the instruments disclosed herein. The needle 4216 may be like theneedle 300 of FIGS. 3A-3C, or it may have an arcuate or U-shapedcross-sectional shape like the implant manipulator 550 of FIG. 5B. Aneedle 4216 with an arcuate cross-sectional shape is illustrated. Theneedle 4216 includes a suture capture feature 4260 which may be similarto or identical to the suture capture feature 360 of needle 300 shown inFIG. or other suture capture features disclosed herein. The suturecapture feature 4260 may include a first member 4250, a second member4252, a capture hole 4254, and a channel 4256 that extends between thefirst member 4250 and the second member 4252 to provide access to thecapture hole 4254. The first member 4250 and the second member 4252 maybe distally sharpened to easily pierce tissue. In this example, thefirst member 4250 is longer than the second member 4252. This may bebeneficial as the force required to pierce the tissue may be reducedsince only one sharp edge initially needs to penetrate through thetissue instead of two. Once the first tissue piercing edge of member4250 has passed through the tissue the second tissue piercing edge ofmember 4252 may more easily pass through the initial cut in the tissueformed by the passage of the first edge. The needle 4216 and/or slider4232 may be spring loaded or spring biased to remain in, and to returnto, a retracted position except when the slider is urged distally toactuate, or move, the needle distally toward an extended position of theneedle. The needle 4216 may reside completely, or at least partially,within the interior of the intermediate portion 4214 proximal to thecutout section 4220.

Referring to FIG. 43, yet another example of a needle 4416 is shown foruse with the instruments disclosed herein. The needle 4416 may be likethe needle 300 of FIGS. 3A-3C, or it may have an arcuate or U-shapedcross-sectional shape like the implant manipulator 550 of FIG. 5B. Aneedle 4416 with an arcuate cross-sectional shape is illustrated. Theneedle 4416 includes a suture capture feature 4460 which may share somefeatures with the suture capture feature 360 of needle 300 shown in FIG.7A or other suture capture features disclosed herein. The suture capturefeature 4460 may include a first member 4450, a second member 4452, anda channel 4456 that extends between the first member 4450 and the secondmember 4452. The illustrated suture capture feature 4460 may lack adistinct capture hole, instead the channel 4456 may terminate in a fullradius 4457 or a squared end. The first member 3750 and the secondmember 3752 may be distally sharpened to easily pierce tissue. Thechannel 4456 may be narrower than the uncompressed diameter of thesuture 710 so that the channel 4456 receives the suture 710 with africtional fit and releases the suture 710 when tension is applied tothe suture 710. This arrangement may be suitable when the needle is tobe used to push suture through tissue instead of pulling suture throughtissue as with needle 300. The needle 4416 and/or slider 4432 may bespring loaded or spring biased to remain in, and to return to, aretracted position except when the slider is urged distally to actuatethe needle distally toward an extended position of the needle. Theneedle 4416 may reside completely, or at least partially, within theinterior of the intermediate portion 4414 proximal to the cutout section4420.

Referring to FIG. 44, a distal portion of yet another instrument 4400 isshown. Instrument 4400 may also be a suture passer, and may be suitablefor passing suture through tissue anywhere in the body, such as themeniscus 3626 in the knee 3600. The instrument 4400 may have a proximalend 4410 (not shown), a distal end 4412, and an intermediate portion4414 between the proximal end 4410 and the distal end 4412. The proximalend 4410 may be identical to any of the proximal ends disclosed herein.The instrument 4400 may use the rigid needle 4416 of FIG. 43 to passsuture through tissue. This example shows that two or more needles maybe included in the instrument 4400, or any of the instruments disclosedherein, including those instruments for which only the distal end isdiscussed.

Referring to FIGS. 44-47, the distal end 4412 may have a cutout section4420, a distal wall 4422, and a base 4424 opposite the distal wall 4422.The cutout section 4420 may be between the distal wall 4422 and the base4424. The cutout section 4420 may provide a location for tissue to beinserted between the at least partially retracted needles 4416, 4416′and the distal wall 4422. The distal wall 4422 may be formed as a singlepiece (i.e., unitarily formed) with the cutout section 4420, and maythus be a stationary feature. This may provide additional rigidity atthe distal end 4412, particularly when the tissue is being pinchedbetween the needle tip and the distal wall 4422. Alternatively, thedistal wall 4422 may be replaced by a jaw that pivots relative to thecutout section 4420 in a manner similar to that of the jaw 2222 of FIG.22. A window 4434 may extend at least partially through the distal wall4422 to accommodate passage of the distal end of the needle 4416. Thewindow 4434 may extend longitudinally as shown, and may extend laterallythrough the distal wall 4422 in one or two dimensions, i.e., the heightand/or width of the distal wall.

The distal end 4412 may include a suture capture feature 4440, as seenbest in FIG. 47. The suture capture feature 4440 may be in or near thewindow 4434; in the illustrated example, some portions of the suturecapture feature 4440 extend into the window 4434 and other portions ofthe suture capture feature 4440 are adjacent to the window 4434. Thesuture capture feature 4440 receives and retains suture, and may besimilar to, or identical to, other suture capture features disclosedherein. In the illustrated example, the suture capture feature 4440includes at least one suture capture element 4442, and is shown with twosuture capture element 4442, 4444 in a facing relationship. Each suturecapture element includes a base 4446 and a tab 4448 which extendsobliquely from the base 4446. The illustrated base 4446 and tab 4448 areboth plate-like elements, and the suture capture elements 4442, 4444 maybe stamped or cut from sheet metal. The base 4446 may include a hole4462. The tab 4448 may include a gripping end 4464 opposite the base4446. The gripping end 4464 may include roughening, teeth, serrations,ridges, grooves, hooks, adhesive, silicone, or other feature, treatment,coating, or modification to enhance the ability to grip and retainsuture. Teeth are shown along the gripping ends 4464 in FIG. 47. Eachsuture capture element 4442, 4444 is coupled to the distal end 4412 sothat the base 4446 is adjacent to the window 4434 and the tab 4448extends obliquely from the base 4446 into the window 4434. Furthermore,the suture capture elements 4442, 4444 are coupled to the distal end4412 on opposite sides of the window 4434 so that the gripping ends 4464are facing each other. The tabs 4448 may be directionally biased, asshown, so that the advancing tip of a needle easily pushes the tabsaside, but the tabs close upon and grasp the suture as the needle iswithdrawn. In some examples, the suture capture feature 4440 may standalone, meaning that there is no distinct window framed by distal wallmaterial. In one such example, the suture capture feature 4440 mayinclude suture capture element 4444 alone. In another such example, thesuture capture feature 4440 may include suture capture element 4442,4444 in a facing relationship, but rotated 90° from the orientationshown in FIG. 47.

The window 4434, suture capture feature 4440, and/or suture captureelement 4442, 4444 may together or separately be referred to as a sutureholding feature or a target for the needle 4416.

The distal end 4412 may include a hole 4426 extending longitudinallythrough the base 4424. The base 4424 may also include at least one slot,hole, or other feature that receives suture. In FIG. 45, three slots4428, 4430, 4432 are shown arranged around the hole 4426. At least oneof the slots 4428, 4430, 4432 may be aligned with, or coaxial with, aneedle channel; in the example, slots 4428, 4432 are aligned with, orcoaxial with, channels 4456, 4456′. The slots 4428, 4430, 4432 may bewider than, equal to, or narrower than the uncompressed diameter of thesuture. The base 4424 is fixedly coupled to the intermediate portion4414, and thus may be considered part of the intermediate portion 4414.Any of the distal ends disclosed herein may include a base with a holeand/or suture receiving feature(s) like the base 4424, hole 4426, andslots 4428, 4430, 4432.

The intermediate portion 4414 may be similar to the intermediateportions 2214, 1214, or other intermediate portions disclosed herein.The intermediate portion 4414 may have a shaft 4441 that is of adequatelength such that the proximal end 4410 may remain outside the body whilethe distal end 4412 is inserted through a working portal or cannula toreach a joint space, a wound, or another anatomical region that requiressuturing.

Referring to FIG. 44, two or more needles 4416 may be included in theinstrument 4400. Two needles 4416, 4416′ are shown in an over-and-underfacing relationship. In some examples, the needles may face away fromeach other, or may all face the same way. The needles may be in aside-by-side relationship. Each needle may be independently actuated.Alternatively, the needles may be synchronized to actuate simultaneouslyor according to a desired sequence. The needle 4416 and/or 4416′ may bespring loaded or spring biased to remain in, and to return to, aretracted position except when actuated distally toward an extendedposition of the needle. In the retracted position, the needle 4416and/or 4416′ may reside completely, or at least partially, within theinterior of the base 4424 proximal to the cutout section 4420. Theneedle 4416 or 4416′ is in a partially retracted position when thedistal tip of the needle is in the proximal half of the cutout section4420, and is in a partially extended position when the distal tip of theneedle is in the distal half of the cutout section. FIG. 44 shows thefirst needle 4416 in a partially retracted position and the secondneedle 4416′ in a partially extended position. The needles 4416 and4416′ each have an extended position in which the first member 4450 andthe second member 4452 are received in the window 4434.

Referring to FIG. 45, the instrument 4400 may be provided with theneedles 4416, 4416′ in a retracted position, pre-loaded with a suture710. Alternatively, the suture 710 may be loaded by a user at the timeof use. Suture may be loaded with the needles fully retracted within thebase 4424 for safety. A first free end 709 of the suture 710 may passinto the base 4424 through slot 4430, then through channel 4456 ofneedle 4416, then out of the base 4424 through slot 4428; and a secondfree end 711 of the suture 710 may pass into the base 4424 through slot4430, then through channel 4456′ of needle 4416′, then out of the base4424 through slot 4432. Each suture free end 709, 711 bends at leastonce going from slot 4430 to channel 4456, 4456′.

Other suture loading configurations, or routings, are contemplated. Forexample, in a side-by-side arrangement of the needles 4416, 4416′, thebase may include four slots so that the suture free ends 709, 711 mayextend straight through the respective needle channel 4456, 4456′ andcorresponding slots. Alternatively, two separate sutures may be loaded,one engaging needle 4416 and the other engaging needle 4416′.

A method of using instrument 4400 may include some or all of thefollowing steps: loading the suture 710 in the needles 4416, 4416′;manipulating the instrument 4400 to position a tissue portion (notshown) in the cutout section 4420; targeting a first location on thetissue; actuating the first needle 4416 to penetrate the first locationon the tissue portion (FIG. 46) and push the suture 710 into the suturecapture feature 4440; retracting the first needle 4416 to a retractedposition, leaving the suture 710 in the suture capture feature 4440;manipulating the instrument 4400 to re-position the tissue portion inthe cutout section 4420; targeting a second location on the tissue;actuating the second needle 4416′ to penetrate the second location onthe tissue portion and push the suture 710 into the suture capturefeature 4440; retracting the second needle 4416′ to a retractedposition, leaving the suture 710 in the suture capture feature 4440; andremoving the instrument 4400 from the body, pulling the suture 710 withit.

A modified version (not shown) of the instrument 4400 may include needle3716 instead of needle 4416′, in an arrangement like that shown in FIGS.44-45. In this version, the distal wall may be modified to include aportion with the suture capture feature 4440 for engagement with needle4416, and a portion with a window and a slot, like window 3734 and slot3738 for engagement with needle 3716. The suture capture feature 4440may include only one suture capture element 4442, and the window andslot may take the place of suture capture element 4444. This modifiedversion provides one needle 4416 with suture-pushing capabilities, andone needle 3716 with suture-pulling capabilities. Needle 3716 couldinstead substitute for needle 4416, in which case the suture capturefeature 4440 and window/slot would be reversed as well.

Referring to FIGS. 48-51, a distal portion of yet another instrument4800 is shown. Instrument 4800 may also be a suture passer, and may besuitable for passing suture through tissue anywhere in the body, such asthe meniscus 3626 in the knee 3600. The instrument 4800 may have aproximal end 4810 (not shown), a distal end 4812, and an intermediateportion 4814 between the proximal end 4810 and the distal end 4812. Theproximal end 4810 may be identical to any of the proximal ends disclosedherein. The instrument 4800 may use the rigid needle 3716 of FIG. 42A topass suture through tissue. In this example, needle 3716 is shown withan optional longitudinal slot 3717. Instrument 4800 may be amodification of instrument 3700 that includes a pusher component. Any ofthe other instruments disclosed herein may be similarly modified toinclude one or more pusher components. The pusher component providespushing arms that may be used to release the suture from the suturecapture feature 3760 of the needle 3716.

Referring to FIG. 48, the distal end 4812 may have a cutout section 4820and a distal wall 4822. The cutout section 4820 may provide a locationfor tissue to be inserted between the retracted needle 4816 and thedistal wall 4822. The distal wall 4822 may be oriented transversely to,or generally perpendicular to, the intermediate portion 4814, in otherwords forming an angle of 45° to 135° with respect to the longitudinalaxis of the intermediate portion 4814. FIG. 48 shows a distal wall 4822which is substantially perpendicular to the intermediate portion 4814.The distal wall 4822 may be formed as a single piece (i.e., unitarilyformed) with the cutout section 4820, and may thus be a stationaryfeature. This may provide additional rigidity at the distal end 4812,particularly when the tissue is being pinched between the needle tip andthe distal wall 4822. Alternatively, the distal wall 4822 may bereplaced by a jaw that pivots relative to the cutout section 4820 in amanner similar to that of the jaw 2222 of FIG. 22. A window 4834 mayextend at least partially through the distal wall 4822 to accommodatepassage of the distal end of the needle 4816 in line with theintermediate portion 4814. The window 4834 may extend longitudinally asshown, and may extend laterally through the distal wall 4822 in one ortwo dimensions, i.e., the height and/or width of the distal wall. Thedistal end of the window 4834 may have a central post 4836 (not shown)that can be used to support the suture 710 and may be used to spread thesuture capture feature 4860 on the needle 4816 as previously described.In some examples, the post 4836 may stand alone, meaning that there isno distinct window framed by distal wall material. A slot 4838 may beprovided to temporarily capture a section of a suture such as the suture710. The slot 4838 may extend across a proximal face of the window 4834,and may be narrower than an uncompressed diameter of the suture 710. Thenarrow width of the slot 4838 may enable the slot 4838 to securely holdthe suture 710 to temporarily capture it, while remaining able torelease the suture 710 in response to application of a small removalforce, such as that applied to the suture 710 such as when it is beingretrieved by the needle 4816. The slot 4838 may optionally have a bossor other positive feature (not shown) such as a bump, wedge, or bulgethat provides a secondary constraint on the suture. The window 4834,post 4836, and/or slot 4838 may together or separately be referred to asa suture holding feature or a target for the needle 4816. The distalwall 4822 may terminate in a distal tip 4818 which may include a sharp,blade-like extension 4819 that may be used to cut into or throughvarious tissues such as tendons or ligaments. FIG. 48 shows a blade-likeextension 4819 which is divided into two portions by the slot 4838,wherein the blade-like extension 4819 is beveled on two sides.

The intermediate portion 4814 may be similar to the intermediateportions 2214, 1214, or other intermediate portions disclosed herein.The intermediate portion 4814 may have a shaft 4840 that is of adequatelength such that the handle 4830 and the chassis 4828 may remain outsidethe body while the distal end 4812 is inserted through a working portalor cannula to reach a joint space, a wound, or another anatomical regionthat requires suturing.

The pusher component 4866 includes a distal portion 4868 and a shaft4870. The distal portion 4868 includes at least one pushing arm 4872.The illustrated example also shows a second pushing arm 4874. There maybe a gap, slot, or space 4876 between the first and second pushing arms4872, 4874. The space 4876 may receive the needle 3716 with clearance sothat the arms 4872, 4874 are on opposite sides of the needle 3716. Theshaft 4870 extends longitudinally beside the needle 3716 in theintermediate portion 4814 of the instrument 4800. The pusher component4866 may be actuated independently of the needle 3716, and may travelparallel to the needle 3716. The pusher component 4866 may be movablebetween a retracted position, in which the pusher component residescompletely within the intermediate portion 4814, and an extendedposition, in which the pusher component extends against the slot 4838 ofthe distal end 4812. The pusher component 4866 may be spring loaded orspring biased to remain in, and to return to, a retracted positionexcept when its user control is urged distally to actuate, or move, thepusher component 4866 distally toward the extended position.

A method of using the instrument 4800 may be similar to the method ofusing instrument 3700 and/or instrument 4400 set forth above. The methodmay include the steps of: loading the suture 710 in the suture capturefeature 3760 of the needle 3716; manipulating the instrument 4800 toposition a tissue portion (not shown) in the cutout section 4820;targeting a first location on the tissue; actuating the needle 3716 topenetrate the first location on the tissue portion (FIG. 48) and pushthe suture into the slot 4838; actuating the pusher component 4866distally so that the pusher arms 4872, 4874 push the suture 710 into theslot 4838; maintaining pressure against the suture 710 with the pusherarms 4872, 4874 while retracting the needle 3716; retracting the pushingarms 4872, 4874, leaving the suture 710 in the slot 4838; manipulatingthe instrument 4800 to re-position the tissue portion in the cutoutsection 4820; targeting a second location on the tissue; actuating theneedle 3716 to penetrate the second location on the tissue portion,enter the window 4834, and capture the suture 710 in the suture capturefeature 4860; retracting the needle 3716 with the captive suture 710 toa retracted position; and removing the instrument 4800, pulling thesuture 710 with it.

The preceding disclosure of needles and other implant manipulators hasfocused on the distal portion of the needle, otherwise known as thepoint of the needle, and the intermediate portion of the needle,otherwise known as the shaft or selectively bendable portion. Theproximal portion of the needle, or shank, may be connected to a separateshaft or other component of an instrument.

FIG. 52 is an exploded view of the needle 3716 and a shaft 5202, withtypical prior art interconnection features. The needle 3716 is now shownwith an optional hole 3715 in the shank opposite the suture capturefeature 3760. The shaft 5202 includes a tongue 5204 which is reduced insize compared to the shaft 5202, and shaped for complementary fitagainst the shank of the needle 3716. The tongue 5204 carries a boss orpost 5206 which fits in the hole 3715. In prior art systems, the needle3716 is fixed to the shaft 5202 by an interference fit between the post5206 and the hole 3715, by welding using the post as sacrificial fillermaterial, by peening the post to retain the needle 3716, or the like.

FIGS. 53A-D show the needle 3716 modified to include a tubular shank5302. In other words, this version of the needle 3716 may be fabricatedfrom a piece of tubing, such as metal or plastic tubing, morespecifically stainless steel, titanium, nitinol, polyetheretherketone(PEEK) or other similar materials. The tubing may be round or circularin cross section as shown, or triangular, square, rectangular,polygonal, oval, or another shape. The needle 3716 with shank 5302 mayhave a uniform cross-sectional shape along the entire length of theneedle, even though material may have been removed from thecross-sectional shape in some places, for example to form the distal andintermediate portions of the needle, a slot through the needle, or asuture capture feature in the needle. The shank 5302 may include holesor slots or other interconnection features for connection to a shaft orother component of an instrument. The needle 3716 illustrated in FIGS.53A-D simplifies the corresponding instrument (suture passer) and itsassembly procedure by reducing the number of component parts and thenumber of steps in the assembly procedure. This shank style may be usedin any of the instruments disclosed herein.

With brief reference to FIGS. 3A, 4A, 5A, 5C, 5D, and 5E, the tubing ofa corresponding tubular shank of needle 300, needle 400, implantmanipulator 500, implant manipulator 592, implant manipulator 593,and/or implant manipulator 594 may be triangular, quadrilateral,parallelogram, rhombus, trapezoid, diamond-shaped, square, orrectangular in cross section.

With brief reference to FIGS. 5B, 5G, and 5H, the tubing of acorresponding tubular shank of implant manipulator 550, implantmanipulator 596, and/or implant manipulator 597 may be D-shaped, round,circular, oval, elliptical, or ovoid in cross section.

With brief reference to FIG. 5F, the tubing of a corresponding tubularshank of implant manipulator 595 may be quadrilateral, pentagonal, orhexagonal in cross section.

Referring to FIG. 53A, the needle 3716 with tubular shank 5302 may befabricated by cutting a piece of tubing along a profile that extends atleast partially along the length of the needle, such as the profileshown between points 5304 and 5306. The profile may be cut in multiplesteps. For example, details of the distal end of the needle may be cutseparately from the rest of the profile. Sharpening may also beperformed as a separate step. Cutting or material removal may beperformed by milling, grinding, electric discharge machining (EDM),sawing, side cutting, end cutting, lapping, honing, water jet cutting,laser cutting, or other material removal processes.

Hybrid needle designs are also contemplated. FIGS. 54A-55B illustratesome examples of hybrid needles. Hybrid needles may be used in any ofthe instruments disclosed herein.

Referring to FIGS. 54A-B, a needle 5400 may include a distal tip portion5402 and a separate proximal portion 5404. FIG. 54A shows that whenassembled, the resulting needle 5400 may resemble needle 3716.

The distal tip portion 5402 may include a suture capture feature 5406,which may be one of the previously disclosed suture capture features,such as suture capture feature 3760 or 764 or 360. The distal tipportion 5402 may include a tab, boss, or base 5408 which extendsopposite the suture capture feature 5406. The base 5408 may includeroughening, teeth, serrations, ridges, grooves, hooks, or other feature,treatment, coating, or modification to enhance fixation with theproximal portion 5404. The distal tip portion 5402 may be made of metalor plastic, such as stainless steel, titanium, nitinol, PEEK, or otherengineering resin.

The proximal portion 5404 may be an elongated part that replicates theintermediate portion and the proximal end of the needle 3716. Theproximal portion 5404 is shown with an arcuate cross-sectional shape.However, the proximal portion 5404 may have any of the cross sectionalshapes disclosed herein, or it may be polygonal, rectangular, round,oval, or trapezoidal. It will be appreciated that the cross sectionalgeometry of the proximal portion 5404 may be modified to produce desiredbending characteristics using the same principles set forth previouslyin the disclosure relating to selectively bendable needles. The proximalportion 5404 may be made of polyurethanes, nylons or other polymers forflexibility.

The needle 5400 may be made by fabricating a distal tip portion 5402,placing the distal tip portion 5402 in a mold, and overmolding theproximal portion 5404 over at least the base 5408. The finished needle5400 includes a stiff distal tip portion 5402 and a flexible polymerproximal portion 5404, and functions the same as the selectivelybendable embodiments disclosed previously.

Referring to FIGS. 55A-B, yet another needle 5500 may include a spine5502 and a needle body 5504.

The spine 5502 is an elongated part that replicates the function of thepreviously disclosed spines herein. The illustrated example is arectangular solid with a beveled distal tip 5506. The spine 5502 maytake on other cross sectional shapes, such as polygonal, trapezoidal,round, oval, T-shaped, I-shaped, or other relevant stiff shapes. Thespine 5502 may be an extrusion. The spine 5502 may be made of metal orplastic, such as stainless steel, titanium, nitinol, PEEK, or otherengineering resin.

The needle body 5504 may be identical to needle 3716, including a suturecapture feature 5508. The needle body 5504 may be made of polyurethanes,nylons, PEEK, engineering resins, or other polymers.

The needle 5500 may be made by fabricating a spine 5502, placing thespine 5502 in a mold, and overmolding the needle body 5504 over at leasta portion of the spine 5502. The finished needle 5500 functions the sameas the rigid embodiments disclosed previously.

Referring to FIGS. 56-58, a distal portion of yet another instrument5600 is shown. Instrument 5600 may also be a suture passer, and may besuitable for passing suture through tissue anywhere in the body, such asthe meniscus 3626 in the knee 3600 or a labrum in a shoulder or hipjoint. The instrument 5600 may have a proximal end 5610 (not shown), adistal end 5612, and an intermediate portion 5614 between the proximalend 5610 and the distal end 5612. The proximal end 5610 may be identicalto any of the proximal ends disclosed herein. The instrument 5600 mayuse a rigid needle 3716 to pass suture through tissue. Instrument 5600may also be outfitted with the pusher component 4866 described forinstrument 4800.

The distal end 5612 may have a cutout section 5620 and a distal wall5622. The cutout section 5620 may provide a location for tissue to beinserted between the at least partially retracted needle 3716 and thedistal wall 5622. The distal wall 5622 may be oriented transversely to,or generally perpendicular to, the intermediate portion 5614, in otherwords forming an angle of 45° to 135° with respect to the longitudinalaxis of the intermediate portion 5614. FIG. 56 shows a distal wall 5622which is substantially perpendicular to the intermediate portion 5614.The distal wall 5622 may be formed as a single piece (i.e., unitarilyformed) with the cutout section 5620, and may thus be a stationaryfeature. This may provide additional rigidity at the distal end 5612,particularly when the tissue is being pinched between the needle tip andthe distal wall 5622. Alternatively, the distal wall 5622 may bereplaced by a jaw that pivots relative to the cutout section 5620 in amanner similar to that of the jaw 2222 of FIG. 22. A window 5634 mayextend at least partially through the distal wall 5622 to accommodatepassage of the distal end of the needle 3716 in line with theintermediate portion 5614. The window 5634 may extend longitudinally asshown, and may extend laterally through the distal wall 5622 in one ortwo dimensions, i.e., the height and/or width of the distal wall. Thedistal end of the window 5634 may have a central post 5636 (FIG. 58)that can be used to support the suture 710 and may be used to spread thesuture capture feature 5660 on the needle 3716 as previously described.In some examples, the post 5636 may stand alone, meaning that there isno distinct window framed by distal wall material. A slot 5638 may beprovided to temporarily capture a section of a suture such as the suture710. The slot 5638 may extend across a proximal face of the window 5634,and may be narrower than an uncompressed diameter of the suture 710. Thenarrow width of the slot 5638 may enable the slot 5638 to securely holdthe suture 710 to temporarily capture it, while remaining able torelease the suture 710 in response to application of a small removalforce, such as that applied to the suture 710 such as when it is beingretrieved by the needle 3716. The slot 5638 may optionally have a bossor other positive feature (not shown) such as a bump, wedge, or bulgethat provides a secondary constraint on the suture. The window 5634,post 5636, and/or slot 5638 may together or separately be referred to asa suture holding feature or a target for the needle 3716. In thisexample, the proximal portion of the slot 5638 extends laterally throughone side of the distal end 5612 in the cutout section 5620, forming anenlarged lateral alcove 5642 along the cutout section 5620. The slot5638 is thus open and accessible from a lateral direction for engagingwith, disengaging from, or manipulating a suture. This arrangement maybe referred to as side loading. The distal wall 5622 adjacent to thealcove 5642 extends proximally, terminating in a proximally-projectingfree end 5646. The distal wall 5622 and the free end 5646 may also bedescribed as a forming a hook. A side loading configuration similar to,or identical to, slot 5636, alcove 5642, and free end 5646 may bepresent in any of the distal ends disclosed herein. The distal wall 5622may support one or more proximally-facing protrusions 5644, which may bespikes, teeth, serrations, ridges, grooves, or otherproximally-projecting features. The protrusion(s) 5644 may be beveled,pyramidal, conical, sharpened, or rough. Two four-sided pyramidalprotrusions 5644 are shown on either side of the slot 5638 near thewindow 5634. The protrusion(s) 5644 may stabilize the distal end 5612against tissue as the needle 3716 is passed through the tissue, and maybe present in any of the distal ends disclosed herein.

The intermediate portion 5614 may be similar to the intermediateportions 2214, 1214, or other intermediate portions disclosed herein.The intermediate portion 5614 may have a shaft 5640 that is of adequatelength such that the proximal end 5610 may remain outside the body whilethe distal end 5612 is inserted through a working portal or cannula toreach a joint space, a wound, or another anatomical region that requiressuturing.

The needle 3716 may be spring loaded or spring biased to remain in, andto return to, a retracted position except when actuated, or moved,distally toward an extended position of the needle. The needle 3716 mayreside completely, or at least partially, within the interior of theintermediate portion 5614 proximal to the cutout section 5620. Theneedle 3716 is in a partially retracted position when the distal tip ofthe needle is in the proximal half of the cutout section 5620, and is ina partially extended position when the distal tip of the needle is inthe distal half of the cutout section.

Instrument 5600 may be used according to the method set forth above forinstrument 3700.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, Figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. § 112 Para. 6. It will be apparent to those having skillin the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the invention. Embodiments of the invention in which anexclusive property or privilege is claimed are defined as follows.

While specific embodiments and applications of the present inventionhave been illustrated and described, it is to be understood that theinvention is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent invention disclosed herein without departing from the spirit andscope of the invention.

1. A suture passer system for a suture comprising a first free end, asecond free end opposite the first free end, and a middle portionbetween the first free end and the second free end, the suture passersystem comprising: a suture passer comprising a proximal end, a distalend opposite the proximal end, an intermediate portion coupled to andextending between the proximal end and the distal end, and a firstneedle residing at least partially within the intermediate portion;wherein the distal end of the suture passer comprises a suture holdingfeature; wherein a distal end of the first needle comprises adistally-sharpened first member, a distally-sharpened second member, anda channel extending between the first member and the second member;wherein the first needle is movable between a retracted position and anextended position, wherein the first needle resides at least partiallywithin the intermediate portion of the suture passer when the firstneedle is in the retracted position, wherein the first needle extends tothe suture holding feature in the distal end of the suture passer whenthe first needle is in the extended position; wherein the suture istransferred between the distal end of the suture passer and the firstneedle when the first needle moves between the retracted position andthe extended position.
 2. The suture passer system of claim 1, whereinthe suture holding feature comprises a slot extending across the distalend of the suture passer, wherein the suture is transferred between theslot and the channel when the first needle moves between the retractedposition and the extended position.
 3. The suture passer system of claim2, wherein the first needle comprises a capture hole, wherein thechannel provides access to the capture hole; wherein the suture istransferred between the slot and the capture hole when the first needlemoves between the retracted position and the extended position.
 4. Thesuture passer system of claim 3, comprising: a pusher componentcomprising a shaft and a distal portion extending from the shaft, thedistal portion comprising at least one pushing arm; wherein the pushercomponent is movable between a retracted position and an extendedposition, wherein the pusher component resides at least partially withinthe intermediate portion of the suture passer when the pusher componentis in the retracted position, wherein the pusher component extendsagainst the slot of the distal end of the suture passer when the pushercomponent in the extended position; wherein the suture is transferredfrom the capture hole to the slot when the first needle is in theextended position and the pusher component moves between the retractedposition and the extended position.
 5. The suture passer system of claim4, wherein the pusher component is biased to remain in, or toautomatically move to, the retracted position except when the pushercomponent is actuated to move the pusher component distally toward theextended position.
 6. The suture passer system of claim 1, wherein thedistal end of the suture passer comprises a sharp, blade-like extension.7. The suture passer system of claim 1, wherein the suture holdingfeature comprises a first tab coupled to the distal end of the suturepasser, wherein the suture is transferred from the channel to the firsttab when the first needle moves between the retracted position and theextended position.
 8. The suture passer system of claim 1, wherein thedistal end of the suture passer comprises a distal wall and a baseopposite the distal wall, wherein the base is coupled to theintermediate portion of the suture passer, wherein the base includes atleast one slot that receives the suture, wherein the at least one slotof the base is aligned with the channel of the first needle when thefirst needle is in the retracted position.
 9. The suture passer systemof claim 1, wherein the distal wall comprises at least oneproximally-facing protrusion.
 10. The suture passer system of claim 1,wherein the first needle is biased to remain in, or to automaticallymove to, the retracted position except when the first needle is actuatedto move the first needle distally toward the extended position.
 11. Thesuture passer system of claim 1, comprising: a second needle residing atleast partially within the intermediate portion of the suture passer;wherein a distal end of the second needle comprises a distally-sharpenedfirst member, a distally-sharpened second member, and a channelextending between the first member of the second needle and the secondmember of the second needle; wherein the second needle is movablebetween a retracted position and an extended position, wherein thesecond needle resides at least partially within the intermediate portionof the suture passer when the second needle is in the retractedposition, wherein the second needle extends to the suture holdingfeature in the distal end of the suture passer when the second needle isin the extended position; wherein the suture is transferred between thedistal end of the suture passer and the second needle when the secondneedle moves between the retracted position and the extended position.12. The suture passer system of claim 11, wherein the suture holdingfeature comprises a second tab coupled to the distal end of the suturepasser, wherein the suture is transferred from the channel of the secondneedle to the second tab when the second needle moves between theretracted position and the extended position.
 13. The suture passersystem of claim 11, wherein the suture holding feature comprises a slotextending across the distal end of the suture passer, wherein the sutureis transferred between the slot and the channel of the second needlewhen the second needle moves between the retracted position and theextended position.
 14. The suture passer system of claim 13, wherein thesecond needle comprises a capture hole, wherein the channel of thesecond needle provides access to the capture hole of the second needle;wherein the suture is transferred between the slot and the capture holeof the second needle when the second needle moves between the retractedposition and the extended position.
 15. A suture passer system for asuture comprising a first free end, a second free end opposite the firstfree end, and a middle portion between the first free end and the secondfree end, the suture passer system comprising: a suture passercomprising a proximal end, a distal end opposite the proximal end, anintermediate portion coupled to and extending between the proximal endand the distal end, and a first needle residing at least partiallywithin the intermediate portion; wherein the distal end of the suturepasser comprises a distal wall oriented transversely to the intermediateportion, wherein the distal wall comprises a suture holding feature,wherein the distal wall terminates in a sharp, blade-like extension;wherein the first needle is movable between a retracted position and anextended position, wherein the first needle resides at least partiallywithin the intermediate portion of the suture passer when the firstneedle is in the retracted position, wherein the first needle extends tothe suture holding feature when the first needle is in the extendedposition; wherein the suture is transferred between the distal end ofthe suture passer and the first needle when the first needle movesbetween the retracted position and the extended position.
 16. The suturepasser system of claim 15, wherein the sharp, blade-like extension isdivided into at least two portions by at least one slot.
 17. The suturepasser system of claim 15, wherein at least two sides of the sharp,blade-like extension are beveled.
 18. A suture passer system for asuture comprising a first free end, a second free end opposite the firstfree end, and a middle portion between the first free end and the secondfree end, the suture passer system comprising: a suture passercomprising a proximal end, a distal end opposite the proximal end, anintermediate portion coupled to and extending between the proximal endand the distal end, a first needle residing at least partially withinthe intermediate portion, and a first pusher component residing at leastpartially within the intermediate portion; wherein the distal end of thesuture passer comprises a suture holding feature; wherein the firstpusher component comprises at least one pushing arm extending beside thefirst needle; wherein the first needle comprises a capture hole; whereinthe first needle is movable between a retracted position and an extendedposition, wherein the first needle resides at least partially within theintermediate portion of the suture passer when the first needle is inthe retracted position, wherein the first needle extends to the sutureholding feature when the first needle is in the extended position;wherein the first pusher component is movable between a retractedposition and an extended position, wherein the first pusher componentresides at least partially within the intermediate portion of the suturepasser when the first pusher component is in the retracted position,wherein the first pusher component extends to the suture holding featurewhen the first pusher component is in the extended position; wherein thesuture is transferred from the capture hole of the first needle to thedistal end of the suture passer when the first needle is in the extendedposition and the first pusher component moves between the retractedposition and the extended position.
 19. The suture passer system ofclaim 18, wherein the first pusher component is independently movablerelative to the first needle.
 20. The suture passer system of claim 18,wherein the first pusher component comprises a shaft and a distalportion extending from the shaft, wherein the distal portion comprisesthe at least one pushing arm; wherein the shaft of the first pushercomponent extends beside the needle in the intermediate component of thesuture passer.